| 2026-08-14 |
P960009-S541 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-08-13 |
P860004-S460 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2026-08-10 |
P130021-S187 |
Medtronic Evolut FX Delivery Catheter System; EvolutTranscatheter Aortic Valve System |
30-Day Notice |
NPT |
— |
— |
| 2026-08-08 |
P960009-S540 |
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-08-08 |
P860004-S459 |
SynchroMed Infusion System; Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2026-08-06 |
P240013-S030 |
Sphere-9 Catheter AFR-00001 |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-08-05 |
P100047-S240 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2026-08-04 |
P240013-S029 |
Sphere-9 Catheter and Affera Ablation System |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-07-31 |
P980035-S846 |
Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADSR03, SED01, SES01, SESR01), Adapta, Versa, Sensia IPG (SED |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-07-31 |
P980035-S845 |
Adapta, Versa, Sensia IPG (ADDR06, ADDRS1, ADSR01, ADSR03, ADSR06, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-07-31 |
P980035-S844 |
Adapta, Versa, Sensia IPG (ADDR03, ADDR06, ADSR01, SEDR01, SESR01); Adapta, Versa, Sensia IPG (SEDRL1); Adapta, Versa, S |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-07-31 |
P890003-S487 |
CareLink SmartSync Device Manager Base (24970A) |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-07-31 |
P220012-S075 |
Aurora EV-ICD (DVEA3E4) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-31 |
P220012-S074 |
Aurora EV ICD (DVEA3E4) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-31 |
P150033-S229 |
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) |
30-Day Notice |
PNJ |
— |
— |
| 2026-07-31 |
P150033-S228 |
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) |
30-Day Notice |
PNJ |
— |
— |
| 2026-07-31 |
P010015-S589 |
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-07-31 |
P010015-S588 |
Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-07-28 |
P100047-S239 |
HeartWare® Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2026-07-28 |
P050053-S069 |
Infuse Bone Graft |
Normal 180 Day Track |
NPZ |
— |
— |
| 2026-07-21 |
P120010-S144 |
Enlite Sensor |
30-Day Notice |
OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
| 2026-07-16 |
P980035-S843 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-07-16 |
P220026-S017 |
Symplicity Spyral Renal Denervation System |
Real-Time Process |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2026-07-16 |
P220012-S073 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-16 |
P010015-S587 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-07-14 |
P130021-S185 |
Medtronic Evolut PRO+ Transcatheter Aortic Valve Replacement System; Medtronic Evolut FX Transcatheter Aortic Valve Repl |
Real-Time Process |
NPT |
— |
— |
| 2026-07-10 |
P240013-S026 |
HexaGen RF Generator Software and Remote |
Real-Time Process |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-07-09 |
P170006-S045 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-07-06 |
P960009-S538 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-07-01 |
P980035-S842 |
Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-06-30 |
P230017-S011 |
PulseSelect Pulse Field Ablation (PFA) Catheter |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-06-25 |
P220012-S069 |
Aurora EV ICD DVEA3E4 |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-06-24 |
P930039-S278 |
CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076), Vitatron Crystalline Active Fixation Lead (ICQ09B) |
30-Day Notice |
NVN |
— |
— |
| 2026-06-24 |
P920015-S306 |
Sprint Quattro Lead (6946M) |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-06-24 |
P080006-S193 |
Attain Ability Lead (4196, 4296), Attain Ability Lead (4396), Attain Performa Lead (4298, 4398, 4598), Attain Stability |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2026-06-16 |
P960009-S537 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-06-11 |
P980035-S841 |
Adapta, Versa, Sensia IPG (ADDR03, ADDRL1, ADDRS1, ADSR01, ADVDD01, SED01, SEDR01, SES01); Adapta, Versa, Sensia IPG (SE |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-06-09 |
P140017-S035 |
Melody Transcatheter Pulmonary Valve System, which includes the Melody Transcatheter Pulmonary Valve (Melody TPV) and th |
Real-Time Process |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-06-05 |
P960009-S536 |
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (B35200) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-06-04 |
P150033-S224 |
Micra Scalable Catheter Delivery System (Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS |
Real-Time Process |
PNJ |
— |
— |
| 2026-06-01 |
P200046-S051 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-06-01 |
P170006-S044 |
Avalus Bioprosthesis, Model 400 |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-06-01 |
P140017-S036 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-06-01 |
P130021-S186 |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve |
30-Day Notice |
NPT |
— |
— |
| 2026-05-28 |
P240013-S022 |
Affera Ablation System |
Real-Time Process |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-05-28 |
P140010-S105 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PT A) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-05-22 |
P960009-S535 |
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense (3387S, 3389S, 3550-05, B31010) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-05-21 |
P140010-S104 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter; IN.PACT 018 Paclitaxel-Coated |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-05-20 |
P960009-S531 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-05-15 |
P240013-S025 |
Sphere-9 Catheter and Affera Ablation System |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-05-14 |
P980035-S836 |
Astra S DR MRI IPG (X3DR01);Astra S SR MRI IPG (X3SR01);Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Azur |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-05-14 |
P100047-S238 |
Heart Ware Ventricular Assist System (HVAD) |
30-Day Notice |
DSQ |
— |
— |
| 2026-05-14 |
P010015-S583 |
Percepta Bipolar CRT-P (WlTR0l); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (WlTR02); Serena Quadripolar |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-05-13 |
P960009-S534 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-05-13 |
P240013-S027 |
Sphere-9 Mapping and Ablation Catheter; Tubing Set; Extension Cable |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-05-08 |
P150033-S227 |
Micra Cathode Press Station 2 |
30-Day Notice |
PNJ |
— |
— |
| 2026-05-07 |
P960009-S533 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-05-06 |
P980035-S835 |
CareLink SmartSync Adapta Versa Sensia Application (D00U014) |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-05-06 |
P890003-S485 |
CareLink SmartSync Platform Application (M01A01); CareLink SmartSync Common Application (M01A02); CareLink SmartSync Hos |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-05-01 |
P140010-S103 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-04-30 |
P980035-S834 |
Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-04-30 |
P220012-S072 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-30 |
P150033-S226 |
Micra AV TPS; Micra AV2 TPS; Micra TPS; Micra VR2 TPS |
30-Day Notice |
PNJ |
— |
— |
| 2026-04-30 |
P150033-S223 |
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) |
Real-Time Process |
PNJ |
— |
— |
| 2026-04-30 |
P010015-S581 |
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1TR02); Serena Quadripolar |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-04-28 |
P220012-S071 |
Aurora EV ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-24 |
P240036-S006 |
OmniaSecure MRI SureScan Lead Model 3930M |
Normal 180 Day Track No User Fee |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-04-24 |
P240036-S005 |
OmniaSecure MRI SureScan Lead Model 3930M |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-04-23 |
P980035-S840 |
Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-04-23 |
P140010-S102 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter; IN.PACT 018 Paclitaxel-Coated |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-04-23 |
P010015-S585 |
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-04-22 |
P150033-S225 |
Micra Transcatheter Pacing System |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2026-04-21 |
P240013-S024 |
Sphere-9 Catheter |
Special (Immediate Track) |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-04-15 |
P980050-S146 |
Transvene CS/SVC Lead (6937A) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-15 |
P950024-S117 |
CapSure Epicardial Pacing Lead (4968), CapSure Epicardial Pacing Lead (4965) |
30-Day Notice |
NVN |
— |
— |
| 2026-04-15 |
P930039-S277 |
CapSureFix Lead 5568, CapSureFix Novus Lead (5076), CapSureFix Novus Lead (4076) |
30-Day Notice |
NVN |
— |
— |
| 2026-04-15 |
P920015-S305 |
ACCESS 6717 KIT PIN PLUG (6717), DF-1 Connector Port Pin Plug (6719), IS-1 Connector Port Pin Plug Kit (6725), Sprint Qu |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-04-15 |
P890003-S486 |
CapSure VDD-2 Lead (5038L, 5038S), CapSure VDD-2 Lead (5038), Service Kit-Pacemaker Repair Kit (5873C) |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-04-15 |
P220012-S070 |
Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-15 |
P120017-S040 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2026-04-15 |
P080006-S192 |
Attain Ability Lead, Attain Performa Lead (4398,4598), Attain Performa Lead (4298), Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2026-04-15 |
P010015-S586 |
Attain Bipolar OTW Lead; Attain OTW L V Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-04-13 |
P230017-S010 |
PulseSelect Pulse Field Ablation (PFA) Catheter |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-04-10 |
P100047-S223 |
HEARTWARE VENTRICULAR ASSIST SYSTEM |
Normal 180 Day Track |
DSQ |
— |
— |
| 2026-04-09 |
P170006-S043 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-04-09 |
P140017-S034 |
Melody Transcatheter Pulmonary Valve |
135 Review Track For 30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-04-07 |
P100047-S235 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2026-04-03 |
P960009-S532 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-04-02 |
P240013-S023 |
Sphere-9 Catheter; Tubing Set; Extension Cable |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-03-27 |
P980035-S838 |
Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-03-27 |
P980035-S837 |
Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDRS1, SED01, SEDR01, SES01, VEDR01); Adapta, Versa, Sensia IPG (SEDRL1); Ad |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-03-27 |
P130021-S184 |
Medtronic CoreValve EnVeo PRO Delivery Catheter System; Medtronic Evolut PRO+ Delivery Catheter System; Medtronic Evolut |
30-Day Notice |
NPT |
— |
— |
| 2026-03-27 |
P010015-S584 |
Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-03-25 |
P220026-S016 |
Symplicity Spyral Renal Denervation Catheter |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2026-03-24 |
P200046-S050 |
Harmony Transcatheter Pulmonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-03-20 |
P240013-S021 |
Sphere-9 Catheter (AFR-00001) |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-03-19 |
P050053-S068 |
INFUSE® Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2026-03-09 |
P240036-S004 |
OmniaSecure MRI SureScan Lead Model 3930M |
Normal 180 Day Track |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-03-06 |
P920015-S304 |
HV Splitter/ Adaptor kit |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-03-06 |
P240013-S020 |
Sphere-9 Catheter (AFR-00001) |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-03-06 |
P220012-S068 |
Aurora EV ICD; Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-03-06 |
P200046-S048 |
Harmony TPV System |
Normal 180 Day Track No User Fee |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-03-06 |
P140010-S098 |
IN.PACT 018 Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Normal 180 Day Track |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-03-06 |
P010015-S582 |
Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-03-03 |
P990064-S094 |
Mosaic Neo Mitral Bioprosthesis |
Normal 180 Day Track |
DYE |
— |
— |
| 2026-03-03 |
P240013-S019 |
HexaGen RF Generator |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-02-27 |
P960009-S530 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-02-27 |
P220026-S015 |
Symplicity Spyral Multi-Electrode Renal Denervation Catheter |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2026-02-26 |
P130021-S182 |
CoreValve EnVeo Pro Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2026-02-24 |
P050053-S067 |
INFUSE Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2026-02-23 |
P150033-S222 |
Miera AV TPS; Miera TPS |
30-Day Notice |
PNJ |
— |
— |
| 2026-02-20 |
P120017-S039 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2026-02-18 |
P100047-S234 |
HeartWare® HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2026-02-17 |
P230017-S009 |
PulseSelect Pulsed Field Ablation (PFA) system |
Normal 180 Day Track |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-02-13 |
P920015-S303 |
Sprint Quattro Lead (6935M, 6947); Sprint Quattro Lead (6935, 6947M) |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-02-13 |
P140010-S101 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-02-12 |
P990064-S096 |
Mosaic Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2026-02-12 |
P980043-S086 |
Hancock II Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2026-02-12 |
P980035-S832 |
Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-02-12 |
P970031-S078 |
Freestyle Bioprosthesis |
135 Review Track For 30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-02-12 |
P960009-S528 |
DBS Implantable Neurostimulator Models B35200, B35300; DBS Implantable Neurostimulators Activa Family Models 37601, 3760 |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-02-12 |
P860004-S456 |
Drug Delivery Infusion Pump Model 8667 |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2026-02-12 |
P220012-S067 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-12 |
P200046-S045 |
Harmony Transcatheter Pulmonary Valve |
135 Review Track For 30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-02-12 |
P170006-S040 |
Avalus Bioprostheses |
135 Review Track For 30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-02-12 |
P140017-S033 |
Melody Transcatheter Pulmonary Valve |
135 Review Track For 30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-02-12 |
P130021-S179 |
Evolut PRO, PRO+, FX, FX+ |
135 Review Track For 30-Day Notice |
NPT |
— |
— |
| 2026-02-12 |
P010015-S580 |
Consulta CRT-P C4TR01 Syncra CRT-P C2TR01 |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-02-11 |
P960009-S520 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-02-11 |
P220012-S065 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-11 |
P200046-S046 |
Harmony Delivery Catheter System (HARMONY-DCS) |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-02-11 |
P150033-S221 |
Micra Transcatheter Pacing System (MC1VR01), Micra AV Transcatheter Pacing System (MC1AVR1), Micra VR2 Transcatheter Pac |
30-Day Notice |
PNJ |
— |
— |
| 2026-02-11 |
P130021-S181 |
EnVeo PRO Delivery Catheter System (ENVPRO-16-US), Evolut PRO+ Delivery Catheter System (D-EVPROP2329US, D-EVPROP34US), |
30-Day Notice |
NPT |
— |
— |
| 2026-02-10 |
P980035-S831 |
Adapta, Versa, Sensia IPG (ADDR01, ADDR03, ADDR06, ADDRL1, ADSR03, ADVDD01, SED01, SES01, VEDR01); Adapta, Versa, Sensia |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-02-10 |
P980035-S829 |
Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01); Astra S DR MRI IPG (X3DR01); Astra S SR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-02-10 |
P950024-S116 |
CapSure Epicardial Pacing Lead (4965); CapSure Epicardial Pacing Lead (4968) |
30-Day Notice |
NVN |
— |
— |
| 2026-02-10 |
P930039-S275 |
CapSureFix Novus Lead (5076); CapSureFix Novus Lead (4076); Vitatron Crystalline ActFix Lead (ICF09B); Vitatron Crystall |
30-Day Notice |
NVN |
— |
— |
| 2026-02-10 |
P920015-S302 |
HV Splitter/Adaptor kit 5019 IS-1 Connector Port Pin Plug Kit 6725 Sprint Quattro Lead 6935, 6947 Sprint Quattro Lead 69 |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2026-02-10 |
P890003-S484 |
CapSure VDD-2 Lead 5038, 5038L, 5038S Service Kit-Pacemaker Repair Kit 5873C Vitatron Brilliant S+ VDD Lead IMW14Q, IMW1 |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-02-10 |
P220012-S066 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-10 |
P200046-S049 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-02-10 |
P150033-S220 |
Micra AV2 TPS; Micra VR2 TPS |
30-Day Notice |
PNJ |
— |
— |
| 2026-02-10 |
P130021-S183 |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve; Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtroni |
30-Day Notice |
NPT |
— |
— |
| 2026-02-10 |
P060039-S119 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2026-02-10 |
P010015-S579 |
Attain OTW LV Lead; Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Qua |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-02-10 |
P010015-S578 |
Consulta CRT-P (C4TR01); Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRT-P (W1T |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-02-06 |
P960009-S529 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense (DBS, DBS Neurostimulator Implantable, DBS Neuros |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-02-06 |
P860004-S457 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters (Drug Delivery Infusion Pump 8667) |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2026-02-04 |
P170006-S042 |
Avalus Bioprosthesis Model 400 (40019, 40021, 40023, 40025, 40027, 40029); Avalus Ultra Bioprosthesis Model 400 (400U1 |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-02-04 |
P130021-S180 |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve (EVOLUTPRO-23-US, EVOLUTPRO-26-US, EVOLUTPRO-29-US); Medtron |
30-Day Notice |
NPT |
— |
— |
| 2026-02-03 |
P100047-S236 |
HeartWare® HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2026-01-30 |
P140010-S091 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2026-01-28 |
P980035-S833 |
Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Attesta DR MRl IPG; Attesta DR MRl IPG; |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-01-23 |
P980035-S830 |
Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-01-23 |
P980035-S828 |
Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; Advis |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2026-01-23 |
P220012-S064 |
Aurora EV-ICD System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-01-23 |
P010015-S577 |
Percepta Bipolar CRT-P; Perceota Quadrioolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-01-23 |
P010015-S576 |
Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRTP; Serena Quadripolar CRT-P; Solar |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-01-20 |
P860004-S443 |
SynchroMed Infusion System, Ascenda ® Intrathecal Catheters |
135 Review Track For 30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2026-01-16 |
P200046-S047 |
Harmony Transcatheter Pulmonic Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2026-01-05 |
P220012-S063 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-12-22 |
P960009-S527 |
Activa Deep Brain Stimulation Therapy System; Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-12-22 |
P860004-S455 |
SynchroMed Infusion System; Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-12-19 |
P860004-S453 |
SynchroMed Infusion Systems |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-12-19 |
P010015-S574 |
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-12-18 |
P960009-S526 |
Activa Deep Brain Stimulation Therapy System, Percept PC; BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-12-17 |
P960009-S514 |
Activa Deep Brain Stimulation Therapy System |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-12-15 |
P220012-S061 |
Aurora EV-ICD System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-12-08 |
P960009-S524 |
Activa Deep Brain Stimulation Therapy System, Percept PC/RC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-12-03 |
P980035-S827 |
Adapta, Versa, Sensia IPG ADDR01, ADDRS1, ADSR03, SES01 LWP, NVZ Adapta, Versa, Sensia IPG SEDRL1 NVZ Adapta, Versa, Sen |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-12-03 |
P980035-S826 |
Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, VEDR01, ADDR03, ADSR03, ADDR01, ADSR06, ADSR01, ADVDD01, SEDR01, ADDR06, SESR0 |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-12-03 |
P890003-S483 |
CareLink SmartSync Device Manager Base 24970A |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-12-03 |
P220012-S062 |
Aurora EV ICD (DVEA3E4) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-12-03 |
P220012-S060 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-12-03 |
P150033-S219 |
Micra AV TPS MC1AVR1 PNJ Micra AV2 TPS MC2AVR1 PNJ Micra TPS MC1VR01 PNJ Micra VR2 TPS MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-12-03 |
P010015-S575 |
Percepta Bipolar CRT-P W1TR01 NKE Percepta Quadripolar CRT-P W4TR01 NKE Serena Bipolar CRT-P W1TR02 NKE Serena Quadripol |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-12-02 |
P150033-S218 |
Micra A V2 TPS (MC2AVR1); Micra VR2 TPS (MC2VR01) |
30-Day Notice |
PNJ |
— |
— |
| 2025-11-26 |
P960009-S525 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-11-26 |
P860004-S454 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Normal 180 Day Track No User Fee |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-11-25 |
P150033-S217 |
Micra Transcatheter Pacing Systems |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2025-11-22 |
P960009-S482 |
Medtronic DBS Therapy for Dystonia |
Panel Track |
SGS |
Deep Brain Stimulation For The Treatment Of Dystonia |
Unknown |
| 2025-11-20 |
P240013-S018 |
Sphere-9 TM Mapping and Ablation Catheter |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-11-13 |
P960009-S521 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-11-13 |
P860004-S451 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-11-10 |
P990064-S093 |
Mosaic Bioprosthesis |
Real-Time Process |
DYE |
— |
— |
| 2025-11-10 |
P980043-S084 |
Hancock II Bioprosthesis |
Real-Time Process |
DYE |
— |
— |
| 2025-11-10 |
P970031-S076 |
Freestyle Bioprosthesis |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-11-10 |
P170006-S038 |
Avalus Bioprosthesis, Avalus Ultra Bioprosthesis |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-11-04 |
P960009-S508 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
— |
— |
— |
| 2025-10-30 |
P890003-S481 |
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 |
Normal 180 Day Track No User Fee |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-10-30 |
P240036-S003 |
OmniaSecure MRI SureScan Lead Model 3930M |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-10-30 |
P170006-S041 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-10-29 |
P240036-S002 |
OmniaSecure MRI SureScan Lead Model 3930M |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-10-28 |
P220012-S059 |
Aurora EV ICD (DVEA3E4) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-10-23 |
P990064-S095 |
Mosaic Bioprosthesis, Models 305, 310 |
30-Day Notice |
DYE |
— |
— |
| 2025-10-23 |
P980043-S085 |
Hancock II Bioprosthesis, Models T505, T510 |
30-Day Notice |
DYE |
— |
— |
| 2025-10-23 |
P970031-S077 |
Freestyle Bioprosthesis, Models 995, 995CS, 995MS |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-10-23 |
P960009-S523 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-10-23 |
P200046-S044 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-10-23 |
P170006-S039 |
Avalus Bioprosthesis, Model 400 |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-10-23 |
P140017-S032 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-10-22 |
P130021-S178 |
Medtronic Evolut PRO+ Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2025-10-16 |
P960009-S522 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-10-16 |
P860004-S452 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-10-10 |
P200028-S026 |
DiamondTemp Ablation System |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-10-08 |
P980035-S824 |
Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-10-08 |
P230017-S008 |
PulseSelect Pulsed Field Ablation (PFA) system |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-10-08 |
P010015-S573 |
Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-10-07 |
P240013-S017 |
Sphere-9 Catheter and Affera Ablation System |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-10-03 |
P980035-S823 |
Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT SR MRI IPG; Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-10-03 |
P220012-S058 |
Aurora EV ICD (DVEA3E4) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-10-03 |
P010015-S572 |
Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-10-02 |
P980035-S825 |
Adapta, Versa, Sensia IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-10-02 |
P980035-S822 |
Advisa DR IPG; Advisa DR MRI IPG; Advisa SR MRI IPG; Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-10-02 |
P010015-S571 |
Percepta Bipolar CRTP; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P; |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-09-19 |
P240013-S016 |
Sphere-9 Catheter and Affera Ablation System |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-09-18 |
P960009-S518 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense (DBS Neurostimulator Implantable B35200); (DBS Ne |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-09-18 |
P860004-S450 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters (Drug Delivery Infusion Pump 8667); (Drug Delivery Infusion |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-09-16 |
P140010-S100 |
IN.PACT Admiral Paclitaxelcoated PTA Balloon Catheter; IN.PACT 018 Paclitaxel-coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-09-15 |
P960009-S519 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-09-11 |
P220012-S054 |
Aurora EV-ICD System |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-05 |
P980035-S821 |
Astra S DR MRI IPG (X3DR01); Astra S SR MRI IPG (X3SR01); Astra XT DR MRI IPG (X1DR01); Astra XT SR MRI IPG (X1SR01); Az |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-09-05 |
P960009-S517 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-09-05 |
P860004-S449 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-09-05 |
P220012-S057 |
Aurora EV-ICD System (DVEA3E4) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-09-05 |
P200046-S043 |
Harmony TPV System |
Special (Immediate Track) |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-09-05 |
P150033-S216 |
Miera AV TPS (MC1AVR1); Miera A V2 TPS (MC2AVR1); Miera TPS (MC1VR01); Miera VR2 TPS (MC2VR01) |
30-Day Notice |
PNJ |
— |
— |
| 2025-09-05 |
P010015-S570 |
Percepta Bipolar CRT-P (W1TR01); Percepta Quadripolar CRT-P (W4TR01); Serena Bipolar CRTP (W1TR02); Serena Quadripolar C |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-09-04 |
P240013-S010 |
Sphere-9 Mapping and Ablation Catheter |
Real-Time Process |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-08-29 |
P860004-S448 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-08-29 |
P240013-S015 |
Sphere-9 Catheter Mapping and Ablation Catheter |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-08-28 |
P960009-S516 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-08-28 |
P860004-S447 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-08-27 |
P130021-S174 |
Evolut PRO+ System, Evolut FX System, Evolut FX+ System |
Panel Track |
NPT |
— |
— |
| 2025-08-21 |
P150033-S215 |
Micra AV TPS (MC1AVR1); Micra AV2 TPS (MC2AVR1); Micra TPS (MC1VR01); Micra VR2 TPS (MC2VR01) |
30-Day Notice |
PNJ |
— |
— |
| 2025-08-21 |
P140017-S031 |
Melody Transcatheter Pumonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-08-20 |
P150033-S208 |
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
Real-Time Process |
PNJ |
— |
— |
| 2025-08-15 |
P240013-S013 |
HexaGen RF Generator, HexaPulse PF Generator, HexaFlow Irrigation Pump |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-08-15 |
P150033-S212 |
Micra Transcatheter Pacing System (Micra AV/VR and Micra AV2/VR2) |
Real-Time Process |
PNJ |
— |
— |
| 2025-08-14 |
P130021-S177 |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve; Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtroni |
30-Day Notice |
NPT |
— |
— |
| 2025-08-12 |
P980035-S820 |
Adapta, Versa, Sensia IPG ADDRL1, ADDRS1, ADSR06; Adapta, Versa, Sensia IPG SED01, SES01; Adapta, Versa, Sensia IPG SED |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-08-12 |
P980035-S818 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-08-12 |
P890003-S482 |
CareLink SmartSync Device Manager Base |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-08-12 |
P220012-S056 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-08-12 |
P150033-S214 |
Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-08-12 |
P140010-S099 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-08-12 |
P140010-S097 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-08-12 |
P010015-S569 |
Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Se |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-08-12 |
P010015-S568 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CR T- |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-08-06 |
P980035-S817 |
Advisa DR IPG (A4DR01); Advisa DR MRI IPG (A2DR01); Advisa SR MRI IPG (A3SR01) |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-08-06 |
P960009-S515 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-08-06 |
P010015-S567 |
Consulta CRT-P (C4TR01); Syncra CRT-P (C2TR01) |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-08-01 |
P240013-S008 |
AFR-00004 HexaGen RF Generator (RFG) and AFR-00008 HexaPulse PF Generator (PFG) |
Real-Time Process |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-07-29 |
P980035-S819 |
Adapta, Versa, Sensia IPG (SED01); Adapta, Versa, Sensia IPG (ADSR01, VEDR01); Adapta, Versa, Sensia IPG (ADVDD01); Adap |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-07-29 |
P220012-S055 |
Aurora EV-ICD System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-07-29 |
P150033-S213 |
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
30-Day Notice |
PNJ |
— |
— |
| 2025-07-23 |
P240013-S014 |
HexaFlow Irrigation Pumo AFR-00004, HexaGen TM RF Generator AFR-00005, HexaPulse TM PF Generator AFR-00008 |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-07-22 |
P960009-S513 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-07-22 |
P240013-S012 |
Sphere-9 Catheter and Affera Ablation System (HexaFlow Irrigation Pump; HexaGen RF Generator; HexaPulse PF Generator) |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-07-17 |
P960009-S511 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-07-17 |
P960009-S510 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-07-17 |
P860004-S446 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-07-17 |
P860004-S445 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-07-16 |
P960009-S512 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-07-16 |
P950024-S115 |
CapSure Epicardial Pacing Lead 4965; CapSure Epicardial Pacing Lead 4968 |
30-Day Notice |
NVN |
— |
— |
| 2025-07-16 |
P930039-S273 |
CapSureFix Novus Lead 5076; Vitatron Crystalline ActFix Lead ICF09B |
30-Day Notice |
NVN |
— |
— |
| 2025-07-16 |
P920015-S301 |
print Quattro Lead 6935M; Sprint Quattro Lead 6947M; Sprint Quattro Lead 6947; Sprint Quattro Lead 6935 |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-07-16 |
P890003-S480 |
CapSure VDD-2 Lead 5038, 5038L, 5038S; Vitatron Brilliant S+ VDD Lead IMW14Q, IMW15Q, IMW16Q; Vitatron Brilliant S+VDD L |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-07-15 |
P960009-S506 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-07-15 |
P890003-S476 |
SmartSync Pacing System Analyzer |
Normal 180 Day Track |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-07-15 |
P140010-S096 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-07-10 |
P140010-S094 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-07-09 |
P920015-S300 |
Sprint Quattro Lead 6935M, Sprint Quattro Lead 6946M, Sprint Quattro Lead 6947, Sprint Quattro Lead 6947M, Sprint Quattr |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-07-09 |
P220012-S053 |
Epsila EV Extravascular Lead EV2401 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-07-09 |
P150033-S211 |
Micra AV TPS MC1lAVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-07-09 |
P140010-S095 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-07-09 |
P140010-S093 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-07-09 |
P100047-S227 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2025-07-07 |
P240013-S011 |
Sphere-9 Catheter and Affera Ablation System |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-07-03 |
P960009-S509 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
— |
— |
— |
| 2025-07-02 |
P980035-S816 |
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-07-02 |
P220012-S052 |
Aurora EV-ICD System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-07-02 |
P150033-S210 |
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
30-Day Notice |
PNJ |
— |
— |
| 2025-07-02 |
P010015-S566 |
MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-06-27 |
P930039-S272 |
CapSureFix Novus Lead; Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2025-06-27 |
P230017-S007 |
PulseSelect Pulsed Field Ablation (PFA) system |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-06-26 |
P990064-S092 |
Mosaic Bioprosthesis, Models 305, 310 |
30-Day Notice |
DYE |
— |
— |
| 2025-06-26 |
P980043-S083 |
Hancock II Bioprosthesis, Models T505, T510 |
30-Day Notice |
DYE |
— |
— |
| 2025-06-26 |
P970031-S075 |
Freestyle Bioprosthesis, Models 995, 995CS, 995MS |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-06-26 |
P240013-S009 |
Sphere-9 Catheter and Affera Ablation System |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-06-26 |
P170006-S037 |
Avalus Bioprosthesis, Model 400 |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-06-26 |
P170006-S036 |
Avalus Bioprosthesis, Model 400 |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-06-26 |
P100047-S230 |
HeartWare Ventricular Assist System (HVAD) |
30-Day Notice |
DSQ |
— |
— |
| 2025-06-20 |
P980035-S814 |
Adapta, Versa, Sensia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-06-20 |
P930039-S271 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2025-06-20 |
P890003-S478 |
2292 Analyzer Cable |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-06-18 |
P980035-S815 |
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-06-18 |
P960009-S507 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-06-18 |
P890003-S479 |
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-06-18 |
P860004-S444 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-06-18 |
P220012-S051 |
Aurora EV-ICD System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-06-18 |
P150033-S209 |
Micra AV TPS MC1AVR1, Micra AV2 TPS MC2AVR1, Micra TPS MC1VR01, Micra VR2 TPS MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-06-18 |
P010015-S565 |
Consulta CRT-P C4TR01; Percepta Bipolar CRT-P W1TR01; Percepta Quadripolar CRTP W4TR01; Serena Bipolar CRT-P W1TR02; Ser |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-06-17 |
P980035-S813 |
Astra S DR MRI IPG, X3DR01; Astra S SR MRI IPG, X3SR01; Astra XT DR MRI IPG, X1DR01; Astra XT SR MRI IPG, X1SR01; Azure |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-06-17 |
P890003-S477 |
CareLink SmartSync Device Manager Base, 24970A |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-06-17 |
P010015-S564 |
Percepta Bipolar CRT- P, WlTR0l; Percepta Quadripolar CRT-P, W4TR01; Serena Bipolar CRT-P, W1TR02; Serena Quadripolar CR |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-06-13 |
P980035-S812 |
Adapta, Versa, Sensia IPG ADDRS1, VEDR01; Adapta, Versa, Sensia IPG ADDR03, ADDRL1, ADSR03, SESR01; Adapta, Versa, Sensi |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-06-13 |
P230017-S006 |
PulseSelect Pulsed Field Ablation (PFA) system |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-06-13 |
P220012-S049 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-06-13 |
P150033-S207 |
Micra AV TPS MC1AVR1; Micra AV2 TPS MC2AVR1; Micra TPS MC1VR01; Micra VR2 TPS MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-06-13 |
P010015-S563 |
Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-06-12 |
P200046-S042 |
Harmony Transcatheter Pulmonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-06-10 |
P960009-S503 |
Activa and Percept Deep Brain Stimulation Therapy System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-06-05 |
P930039-S268 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2025-06-05 |
P100047-S229 |
HeartWare Ventricular Assist System (HVAD) |
30-Day Notice |
DSQ |
— |
— |
| 2025-06-05 |
P090013-S335 |
CapSureFix MRI Lead |
135 Review Track For 30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-06-04 |
P240036-S001 |
OmniaSecure MRI SureScan Lead Model 3930M |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-06-04 |
P100047-S228 |
HEARTWARE VENTRICULAR ASSIST SYSTEM |
30-Day Notice |
DSQ |
— |
— |
| 2025-05-30 |
P980035-S811 |
Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-05-30 |
P920015-S299 |
HV Splitter/Adaptor kit (5019); Sprint Quattro Lead (6947M); Sprint Quattro Lead (6946M); Sprint Quattro Lead (6935M) |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-05-30 |
P240013-S007 |
Sphere-9 Catheter and Affera Ablation System |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-05-30 |
P220012-S050 |
Epsila EV Extravascular Lead (EV2401) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-05-30 |
P010015-S562 |
Consulta CRT-P C4TR01, Percepta Bipolar CRT-P W1TR01, Percepta Quadripolar CRT-P W4TR01, Serena Bipolar CRTP W1TR02, Ser |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-05-29 |
P140010-S092 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter; IN.PACT 018 Paclitaxel-C |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-05-22 |
P240013-S006 |
Sphere-9 Ablation and Mapping Catheter - AFR-00001 |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-05-21 |
P960009-S505 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense TM |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-05-21 |
P860004-S442 |
SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-05-15 |
P220012-S044 |
Epsila EV Transverse Tunneling Tool |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-05-14 |
P080006-S191 |
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2025-05-13 |
P200046-S041 |
Harmony Transcatheter Pulmonic Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-05-06 |
P930039-S263 |
CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead |
Normal 180 Day Track |
NVN |
— |
— |
| 2025-05-06 |
P090013-S333 |
CapSureFix MRI Lead |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-05-05 |
P100047-S226 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2025-05-01 |
P150033-S206 |
Micra Transcatheter Pacing System: MC1AVR1; MC2AVR1; MC1VR01; MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-04-25 |
P980035-S810 |
Advisa DR IPG A4DR01 Advisa DR MRI IPG A2DR01 Advisa SR MRI IPG A3SR01 Astra S DR MRI IPG X3DR01 Astra S SR MRI IPG X3SR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-04-25 |
P220012-S048 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-04-25 |
P150033-S205 |
Micra AV TPS MC1AVR1, MC2AVR1 Micra TPS MC1VR01 Micra VR TPS MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-04-25 |
P010015-S561 |
Consulta CRT-P C4TR01 Percepta Bipolar CRT-P W1TR01 Percepta Quadripolar CRT-P W4TR01 Serena Bipolar CRTP W1TR02 Serena |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-04-24 |
P100047-S225 |
HeartWare® HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2025-04-22 |
P240036 |
OmniaSecure MRI SureScan Lead Model 3930M |
Original |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-04-16 |
P990064-S091 |
Mosaic Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2025-04-16 |
P980043-S082 |
Hancock II Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2025-04-16 |
P970031-S074 |
Freestyle Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-04-16 |
P150033-S204 |
Micra AV TPS MC1AVR1, MC2AVR1; Micra TPS MC1VR01; Micra VR TPS MC2VR01 |
30-Day Notice |
PNJ |
— |
— |
| 2025-04-14 |
P200046-S040 |
Harmony TPV System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-04-11 |
P960009-S504 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-04-10 |
P220026-S012 |
Symplicity G3 Renal Denervation RF Generator; Symplicity Spyral Multi-Electrode Renal Denervation Catheter |
Normal 180 Day Track No User Fee |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2025-04-08 |
P130021-S176 |
Medtronic Evolut PRO+ Transcatheter Aortic Valve; Medtronic Evolut FX Transcatheter Aortic Valve; Medtronic Evolut FX+ T |
30-Day Notice |
NPT |
— |
— |
| 2025-04-07 |
P220026-S011 |
Symplicity Spyral Renal Denervation Catheter |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2025-04-07 |
P200046-S039 |
Harmony Transcatheter Pulmonic Valve (TPV) System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-04-07 |
P200046-S038 |
Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-04-07 |
P130021-S175 |
CoreValve EnVeo Pro Delivery Catheter System; CoreValve EnVeo Pro Loading System; Evolut PRO+ Delivery Catheter System; |
30-Day Notice |
NPT |
— |
— |
| 2025-04-03 |
P980035-S809 |
Astra S DR MRI IPG; Astra S SR MRI IPG; Astra XT DR MRI IPG; Astra XT SR MRI IPG; Azure S DR MRI IPG; Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-04-03 |
P220012-S047 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-04-03 |
P010015-S560 |
Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-04-02 |
P220012-S046 |
Aurora EV ICD DVEA3E4 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-04-02 |
P100047-S224 |
HeartWare HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2025-04-01 |
P920015-S298 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-03-27 |
P150033-S203 |
MEDTRONIC MICRA TRANSCATHETER PACEMAKER SYSTEM |
30-Day Notice |
PNJ |
— |
— |
| 2025-03-27 |
P140017-S030 |
MELODY TRANSCATHETER PULMONARY VALVE (TPV), ENSEMBLE TRANSCATHETER VALVE DELIVERY SYSTEM (DS) |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-03-26 |
P140010-S087 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-03-21 |
P220026-S013 |
Symplicity Spyral Multi-Electrode Renal Denervation Catheter |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2025-03-20 |
P990001-S123 |
Diva Platform Implantable Pulse Generators; PRO VIT Application Software |
135 Review Track For 30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-03-20 |
P980050-S145 |
MEDTRONIC(R) JEWEL(R) AF 7250 DUAL CHAMBER IMPLANTABLE CARDIOVERTER DEFIBRILLATOR, MODEL 9961 PROGRAMMER APPLICATION SOF |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-03-20 |
P980035-S807 |
Medtronic Kappa 700/600 Series Pulse Generators and Model 9953 Software |
135 Review Track For 30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-03-20 |
P970012-S101 |
Medtronic.Kappa 400 Series Pacemakers |
135 Review Track For 30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-03-20 |
P950024-S114 |
Medtronic (R) CapSure (R) EPI Pacing Lead |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2025-03-20 |
P930039-S270 |
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2025-03-20 |
P930022-S020 |
Medtronic(R) Legend Plus(TM) Pulse Generator |
135 Review Track For 30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-03-20 |
P920015-S297 |
Medtronic(R) Transvene Lead System |
135 Review Track For 30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2025-03-20 |
P890003-S475 |
Synergyst II Pulse Generator Models 7070 & 7071 |
135 Review Track For 30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-03-20 |
P850051-S085 |
Activitrax Models 8400, 8402, 8403 |
135 Review Track For 30-Day Notice |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2025-03-20 |
P220012-S043 |
Aurora EV-ICD System |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-03-20 |
P150033-S201 |
Medtronic Micra Transcatheter Pacemaker System |
135 Review Track For 30-Day Notice |
PNJ |
— |
— |
| 2025-03-20 |
P120017-S038 |
Model 5071 Lead |
135 Review Track For 30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2025-03-20 |
P090013-S336 |
Revo MRI Surescan IPG and Pacing System |
135 Review Track For 30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-03-20 |
P080006-S190 |
Medtronic Attain Ability Model 4196 Lead |
135 Review Track For 30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2025-03-20 |
P060039-S118 |
Attain Starfix Model 4195 Lead |
135 Review Track For 30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2025-03-20 |
P010015-S558 |
Medtronic Insync Biventrical Pacing System |
135 Review Track For 30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-03-19 |
P050053-S065 |
INFUSE® Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2025-03-18 |
P980035-S808 |
Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Versa, Sensia IPG; Adapta, Vers |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-03-18 |
P220012-S045 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-03-18 |
P150033-S202 |
Micra AV TPS; Micra TPS; Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2025-03-18 |
P010015-S559 |
Consulta CRT-P; Percepta Bipolar CRT-P; Percepta Quadripolar CRT-P; Serena Bipolar CRT-P; Serena Quadripolar CRT-P; Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-03-14 |
P960009-S502 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-03-14 |
P860004-S441 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-03-14 |
P860004-S440 |
SynchroMed Infusion System; Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-03-14 |
P140010-S089 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitaxe |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-03-13 |
P200046-S037 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-03-13 |
P130021-S173 |
CoreValve Evolut PRO Transcatheter Aortic Valve; Evolut PRO+ Transcatheter Aortic Valve; Evolut FX Transcatheter Aortic |
30-Day Notice |
NPT |
— |
— |
| 2025-03-13 |
P100047-S222 |
HEARTWARE VENTRICULAR ASSIST SYSTEM |
30-Day Notice |
DSQ |
— |
— |
| 2025-03-05 |
P130021-S172 |
MEDTRONIC COREVALVE SYSTEM |
30-Day Notice |
NPT |
— |
— |
| 2025-03-05 |
P130021-S171 |
CoreValve EnVeo PRO Delivery Catheter System; Evolut PRO+ Delivery Catheter System; Evolut FX Transcatheter Aortic Valve |
30-Day Notice |
NPT |
— |
— |
| 2025-02-28 |
P960009-S501 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-02-27 |
P220012-S042 |
Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-02-26 |
P080006-S189 |
Attain Ability Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2025-02-20 |
P980035-S806 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-02-20 |
P960009-S483 |
Activa, Percept and SenSight Deep Brain Stimulation Therapy System |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-02-20 |
P960009-S478 |
Activa®, Percept and SenSight Deep Brain Stimulation Therapy System |
Panel Track |
NHL |
— |
— |
| 2025-02-20 |
P930039-S269 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2025-02-19 |
P130021-S170 |
Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medtronic Evolut Pro+ Transcatheter Aortic Valve, Medtroni |
30-Day Notice |
NPT |
— |
— |
| 2025-02-14 |
P220012-S040 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-02-14 |
P150033-S199 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2025-02-13 |
P860004-S439 |
MEDTRONIC(R) SYNCHROMED(TM) PUMP & INFUSION SYSTEM |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-02-12 |
P960009-S489 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-02-12 |
P860004-S432 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
135 Review Track For 30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-02-12 |
P200046-S036 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2025-02-12 |
P130021-S169 |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic E |
30-Day Notice |
NPT |
— |
— |
| 2025-02-07 |
P960009-S491 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-02-06 |
P150033-S200 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2025-02-03 |
P240013-S003 |
Sphere-9 Catheter and Affera Ablation System |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-01-30 |
P220012-S041 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-01-24 |
P140010-S088 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon, IN.PACT 018 Paclitaxel-Coated Per |
Special (Immediate Track) |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2025-01-22 |
P990064-S089 |
Mosaic Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2025-01-22 |
P980043-S080 |
Hancock II Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2025-01-22 |
P220012-S039 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-01-22 |
P080006-S188 |
Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2025-01-15 |
P960009-S500 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-01-15 |
P860004-S438 |
SynchroMed® Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-01-14 |
P980035-S796 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-01-14 |
P010015-S548 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-01-09 |
P230017-S005 |
PulseSelect Pulsed Field Ablation (PFA) system |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-01-08 |
P980035-S805 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-01-08 |
P890003-S474 |
CareLink SmartSync Device Manager Base, CareLink SmartSync Device Manager Patient Connector, MyCareLink Patient Monitor |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-01-08 |
P220012-S038 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-01-08 |
P150033-S198 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2025-01-08 |
P010015-S557 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-01-07 |
P230017-S004 |
PulseSelect Pulsed Field Ablation (PFA) system |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-01-06 |
P960009-S490 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-01-06 |
P860004-S433 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2025-01-03 |
P980035-S804 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2025-01-03 |
P010015-S556 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-31 |
P960009-S497 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-23 |
P960009-S498 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-23 |
P960009-S486 |
Activa and Percept Deep Brain Stimulation Therapy System |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-23 |
P240013-S005 |
Sphere-9 Mapping and Ablation Catheter |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-12-23 |
P240013-S004 |
Sphere-9 Mapping and Ablation Catheter, Tubing Set |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-12-19 |
P980035-S803 |
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-12-19 |
P920015-S295 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-12-19 |
P150033-S197 |
Micra Transcatheter Pacing System |
30-Day Notice |
PNJ |
— |
— |
| 2024-12-19 |
P150033-S195 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-12-19 |
P010015-S554 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Serena Quadripolar C |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-18 |
P980035-S802 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-12-18 |
P980035-S795 |
Astra S DR MRI IPG,Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, |
135 Review Track For 30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-12-18 |
P960009-S495 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-18 |
P920015-S296 |
Tunneling Tool |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-12-18 |
P860004-S436 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-12-18 |
P220012-S037 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-12-18 |
P150033-S196 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-12-18 |
P010015-S553 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-17 |
P010015-S555 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-13 |
P960009-S492 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-12 |
P960009-S493 |
DBS Neurostimulator Implantable/Activia Family |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-12 |
P860004-S435 |
Drug Delivery Infusion Pump/SynchroMed |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-12-11 |
P220026-S010 |
Symplicity Spyral Renal Denervation System |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-12-09 |
P930039-S266 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-12-05 |
P960009-S496 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-03 |
P140010-S084 |
IN.PACT Admiral DCB |
Real-Time Process |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-12-02 |
P980035-S801 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-12-02 |
P930039-S267 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-11-27 |
P220012-S035 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-25 |
P100047-S221 |
HEARTWARE VENTRICULAR ASSIST SYSTEM |
Normal 180 Day Track |
DSQ |
— |
— |
| 2024-11-22 |
P990034-S045 |
IsoMed Infusion System |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-11-22 |
P890003-S470 |
OUS Vitatron Application Software |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-22 |
P860004-S434 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-11-22 |
P240013-S002 |
Affera Sphere-9 Mapping and Ablation Catheter |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-11-22 |
P240013-S001 |
Sphere-9 Mapping and Ablation Catheter, Catheter Extension Cable, Tubing Set |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-11-22 |
P220012-S036 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-22 |
P140010-S086 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-11-21 |
P980035-S800 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-21 |
P010015-S552 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-20 |
P980035-S799 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-20 |
P220012-S034 |
Aurora EV ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-20 |
P150033-S194 |
Micra AV TPS, Micra TPS, Micra VR TPS |
Real-Time Process |
PNJ |
— |
— |
| 2024-11-20 |
P010015-S551 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-15 |
P890003-S469 |
Carelink SmartSync Platform Carelink SmartSync TM Common Application |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-14 |
P980035-S790 |
CareLink SmartSync Azure Astra App |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-14 |
P890003-S471 |
CareLink SmartSync NuPace Application Software |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-14 |
P150033-S191 |
CareLink SmartSync Micra AV App, CareLink SmartSync Micra Evolution App, CareLink SmartSync Micra VR App |
Real-Time Process |
PNJ |
— |
— |
| 2024-11-14 |
P010015-S545 |
CareLink SmartSync Percepta Serena Solara App |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-13 |
P980050-S144 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-13 |
P980035-S797 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-13 |
P980035-S788 |
Azure/Astra Implantable Pulse Generator (IPG) |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-13 |
P950024-S113 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-11-13 |
P930039-S265 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-11-13 |
P920015-S294 |
DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Le |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-11-13 |
P890003-S473 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-13 |
P220012-S033 |
Aurora EV ICD, Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-13 |
P150033-S193 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-11-13 |
P120017-S037 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2024-11-13 |
P090013-S334 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-13 |
P080006-S187 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2024-11-13 |
P060039-S117 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2024-11-13 |
P010015-S549 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Solara |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-11-06 |
P050053-S064 |
INFUSE Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2024-11-05 |
P980035-S798 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-11-05 |
P960009-S488 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-11-05 |
P010015-S550 |
Consulta CRT-P, Syncra CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-30 |
P220012-S031 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-25 |
P980035-S793 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-10-25 |
P010015-S546 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-24 |
P240013 |
Sphere-9 Catheter and Affera Ablation System |
Original |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-10-21 |
P140010-S085 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
— |
— |
— |
| 2024-10-17 |
P980050-S143 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-17 |
P980035-S794 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-10-17 |
P950024-S112 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-10-17 |
P930039-S264 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-10-17 |
P920015-S293 |
DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead. Subcutaneous Lead, Transvene C |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-10-17 |
P220012-S032 |
Aurora EV ICD, Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-17 |
P150033-S192 |
Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-10-17 |
P120017-S036 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2024-10-17 |
P080006-S186 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2024-10-17 |
P060039-S116 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2024-10-17 |
P010015-S547 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-11 |
P960009-S487 |
Percept Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-10-01 |
P950024-S111 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-10-01 |
P920015-S292 |
IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-10-01 |
P890003-S472 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-09-30 |
P980035-S791 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-09-27 |
P220012-S025 |
Aurora EV-ICD |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-09-27 |
P130021-S168 |
Evolut FX Delivery Catheter System of the Medtronic Evolut FX System |
30-Day Notice |
NPT |
— |
— |
| 2024-09-26 |
P980035-S792 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-09-26 |
P100047-S219 |
HEARTWARE VENTRICULAR ASSIST SYSTEM |
Normal 180 Day Track |
DSQ |
— |
— |
| 2024-09-18 |
P980035-S789 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-09-18 |
P010015-S544 |
Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-09-16 |
P960009-S485 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-09-16 |
P860004-S431 |
SynchroMed Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-09-12 |
P980035-S787 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-09-12 |
P220012-S030 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-09-06 |
P230017-S003 |
PulseSelect PFA Loop Catheter |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-09-04 |
P980035-S786 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-08-30 |
P100047-S220 |
HeartWare® HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2024-08-28 |
P220012-S029 |
Advanced Valve Metal (AVM) capacitor |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-08-21 |
P220026-S009 |
Symplicity G3 Renal Denervation RF Generator |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-08-16 |
P930039-S262 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-08-15 |
P920015-S291 |
Tunneling Tool |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-08-14 |
P860004-S430 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-08-13 |
P200046-S035 |
Harmony Transcathetrer Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-08-13 |
P130021-S167 |
Medtronic Core ValvE Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtronic |
30-Day Notice |
NPT |
— |
— |
| 2024-08-06 |
P200028-S024 |
DiamondTemp Ablation System |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-08-06 |
P100047-S218 |
Heart Ware HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2024-08-01 |
P930039-S261 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-08-01 |
P080006-S185 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2024-07-31 |
P930039-S257 |
CapSureFix Novus Lead |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2024-07-24 |
P130021-S165 |
CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2024-07-22 |
P150033-S185 |
Micra AV TPS, Micra TPS, Micra VR TPS |
135 Review Track For 30-Day Notice |
PNJ |
— |
— |
| 2024-07-21 |
P980035-S785 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-07-21 |
P010015-S543 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-07-17 |
P980035-S784 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-07-17 |
P960009-S484 |
Percept RC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-07-17 |
P010015-S542 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-07-16 |
P220026-S005 |
Symplicity G3 Renal RF Generator |
135 Review Track For 30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-07-05 |
P920015-S290 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-07-03 |
P100047-S217 |
HeartWare HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2024-07-01 |
P960009-S474 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-07-01 |
P930039-S260 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-07-01 |
P930029-S072 |
RF Catheter Cables |
Real-Time Process |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2024-07-01 |
P920015-S289 |
Transvene CS/SVC Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-07-01 |
P890003-S468 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-07-01 |
P090013-S332 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-06-28 |
P960009-S481 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-06-28 |
P860004-S429 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-06-27 |
P980035-S783 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IMG, Astra S DR MRI IG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra X |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-06-27 |
P960009-S480 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-06-27 |
P920015-S288 |
HV Splitter/Adaptor kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-06-27 |
P220012-S028 |
Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-06-27 |
P140010-S081 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter IN.PACT 018 Paclitaxel-Co |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-06-27 |
P080006-S184 |
Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2024-06-27 |
P010015-S541 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-06-21 |
P920015-S287 |
HV Splitter/Adaptor kit |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-06-21 |
P140010-S079 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Real-Time Process |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-06-20 |
P130021-S164 |
Core Valve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Valve EnVeo R Delivery Catheter Sys |
30-Day Notice |
NPT |
— |
— |
| 2024-06-18 |
P230017-S001 |
PulseSelect Pulsed Field Ablation (PFA) system |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-06-05 |
P980035-S782 |
SWCOMBO / Application Software, SW030 / Application Software |
30-Day Notice |
— |
— |
— |
| 2024-06-05 |
P890003-S467 |
SW026, SWCOMBO / Application Software, SW036 / Application Software, 29901 / CareLink Encore Programmer, 2090 / CareLink |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-06-05 |
P220012-S026 |
EAZ101 / Epsila EV Sternal Tunneling Tool, EAZ201 / Epsila EV Transverse Tunneling Tool |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-06-05 |
P150033-S189 |
SW044, SWCOMBO / Application Software, SW022 / Micra AV Programming Software Model |
30-Day Notice |
PNJ |
— |
— |
| 2024-06-05 |
P090013-S331 |
SWCOMBO / Application Software |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-06-05 |
P010015-S539 |
MEDTRONIC INSYNC(TM) BIVENTRICAL PACING SYSTEM |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-06-04 |
P220012-S018 |
Aurora EV-ICD Application Software, Aurora EV-ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-29 |
P220012-S027 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-29 |
P010015-S540 |
Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT- |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-05-24 |
P980035-S781 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-05-24 |
P860004-S427 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-05-24 |
P010015-S538 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-05-23 |
P960009-S479 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-05-23 |
P860004-S428 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-05-23 |
P220012-S023 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-16 |
P860004-S426 |
SynchroMed Infusion Systems |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-05-09 |
P220012-S014 |
Aurora EV ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-08 |
P220026-S007 |
Symplicity Spyral' Multi-Electrode Renal Denervation Catheter |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-05-08 |
P200046-S033 |
Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-05-08 |
P150033-S188 |
Micra TPS, Micra VR TPS, Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-05-08 |
P140010-S080 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and IN.PACT 018 Paclitax |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-05-08 |
P130021-S163 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Sys |
30-Day Notice |
NPT |
— |
— |
| 2024-05-07 |
P980035-S780 |
Advisa DR IPG, Advisa DR MRl IPG, Advisa SR MRl IPG, Astra S DR MRl IPG, Astra S SR MRl IPG, Astra XT DR MRl IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-05-07 |
P130021-S162 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt |
30-Day Notice |
NPT |
— |
— |
| 2024-05-07 |
P010015-S537 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-05-02 |
P220012-S024 |
Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-01 |
P230017-S002 |
PulseSelect Pulsed Field Ablation (PFA) system |
Real-Time Process |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2024-04-29 |
P100047-S215 |
HeartWare HVAD System |
Real-Time Process |
DSQ |
— |
— |
| 2024-04-26 |
P960009-S477 |
Activa Deep Brain Stimulation Therapy System, Percept PC and RC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-04-26 |
P890003-S466 |
Heart Failure Risk Status (HFRS), Triage-HF |
Normal 180 Day Track No User Fee |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-04-25 |
P220012-S021 |
Aurora EV-ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-25 |
P010015-S536 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-04-24 |
P960009-S476 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-04-24 |
P960009-S475 |
DBS Neurostimulators Implantable Activa Family |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-04-24 |
P860004-S425 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-04-24 |
P220012-S020 |
Aurora EV-ICD System |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-22 |
P990064-S088 |
Mosaic Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2024-04-22 |
P980043-S079 |
Hancock II Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2024-04-22 |
P970031-S073 |
Freestyle Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-04-22 |
P870078-S051 |
Hancock Valved Conduit |
30-Day Notice |
DYE |
— |
— |
| 2024-04-22 |
P170006-S034 |
Avalus Bioprosthesis, Avalus Ultra Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-04-22 |
P170006-S033 |
Avalus Bioprosthesis and Avalus Ultra Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-04-19 |
P130021-S161 |
Medtronic Evolut FX+ Transcatheter Aortic Valve, Evolut FX Delivery Catheter System, Evolut FX Loading System |
30-Day Notice |
NPT |
— |
— |
| 2024-04-16 |
P930039-S259 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-04-16 |
P920015-S286 |
HV Splitter, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-04-16 |
P920015-S285 |
Y Adaptor/Extender Kit, Sprint Quattro Lead |
135 Review Track For 30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2024-04-16 |
P220012-S022 |
Epsila EV Extravascular Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-16 |
P150033-S187 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-04-16 |
P080006-S183 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2024-04-11 |
P960009-S472 |
Percept RC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-04-10 |
P890003-S465 |
CareLink SmartSync |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-04-10 |
P220026-S006 |
Symplicity Spyral Renal Denervation System |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-04-10 |
P220012-S019 |
Aurora EV-ICD System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-10 |
P130021-S160 |
Medtronic CoreValve Evolut R System |
30-Day Notice |
NPT |
— |
— |
| 2024-04-09 |
P960009-S470 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-04-09 |
P860004-S424 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-04-08 |
P980035-S779 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-04-04 |
P930039-S258 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-04-04 |
P220012-S017 |
Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-04-02 |
P980035-S777 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-03-30 |
P980035-S778 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-03-26 |
P200046-S032 |
Harmony Transcatheter Pulmonic Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-03-22 |
P200046-S031 |
Harmony TPV System |
Normal 180 Day Track No User Fee |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-03-22 |
P130021-S155 |
Evolut FX+ TAV, Evolut FX DCS, Evolut FX LS |
Normal 180 Day Track |
NPT |
— |
— |
| 2024-03-21 |
P130021-S159 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2024-03-21 |
P100047-S216 |
HeartWare® HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2024-03-11 |
P980035-S775 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-03-11 |
P220012-S015 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-03-11 |
P010015-S534 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-03-08 |
P200046-S030 |
Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-03-08 |
P200046-S029 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-03-08 |
P200028-S023 |
Diamond Temp Catheter |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-03-08 |
P150033-S184 |
Micra AV Transcatheter Pacing System, Micra Transcatheter Pacing System, Micra VR2/AV2 Transcatheter Pacing System |
30-Day Notice |
PNJ |
— |
— |
| 2024-03-08 |
P140017-S029 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-03-08 |
P130021-S158 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst |
30-Day Notice |
NPT |
— |
— |
| 2024-03-08 |
P130021-S157 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2024-03-06 |
P980035-S776 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-03-06 |
P980035-S774 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-03-06 |
P220012-S016 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-03-06 |
P010015-S535 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sol |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-02-29 |
P980035-S772 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-02-29 |
P960009-S473 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-02-29 |
P220026-S004 |
Symplicity Spyral Multi-Electrode Renal Denervation Catheter |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-02-29 |
P220012-S013 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-02-29 |
P010015-S532 |
Consulta CRT-P, Syncra CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-02-28 |
P220026-S003 |
Symplicity Spyral Multi Electrode Renal Denervation Catheter |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-02-23 |
P960009-S471 |
DBS Neurostimulator Implantable |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-02-22 |
P960009-S469 |
DBS Neurostimulators External, DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Activa F |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-02-22 |
P860004-S423 |
Drug Delivery Infusion Pump |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-02-16 |
P860004-S422 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-02-16 |
P220012-S012 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-02-15 |
P220026-S001 |
Symplicity Spyral Multi-Electrode Renal Denervation Catheter, Symplicity G3 Renal Devervation RF Generator |
Normal 180 Day Track No User Fee |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-02-14 |
P980035-S773 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-02-14 |
P010015-S533 |
Consulta CRT-P, Syncra CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-02-13 |
P980035-S771 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-02-13 |
P200046-S028 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-02-13 |
P170006-S032 |
Avalus Bioprosthesis, Avalus Ultra Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-02-13 |
P150033-S183 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-02-13 |
P140017-S028 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-02-13 |
P130021-S156 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2024-02-13 |
P010015-S531 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-02-06 |
P220026-S002 |
Symplicity Spyral Renal Denervation System |
30-Day Notice |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2024-01-31 |
P170006-S025 |
Avalus Ultra Bioprosthesis |
Normal 180 Day Track |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-01-31 |
P140010-S078 |
In.Pact Admiral Paclitaxel-Coated PTA Balloon Catheter, In.Pact 018 Paclitaxel-Coated PTA Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-01-31 |
P140010-S077 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2024-01-31 |
P130021-S152 |
CoreValve EnVeo Pro Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2024-01-30 |
P980035-S770 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-01-30 |
P010015-S530 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-01-29 |
P130021-S154 |
Evolut FX Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2024-01-24 |
P200046-S027 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-01-24 |
P170006-S031 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-01-24 |
P140017-S027 |
MelodyTM Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2024-01-24 |
P130021-S153 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2024-01-12 |
P980035-S769 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2024-01-12 |
P220012-S011 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-01-11 |
P960009-S467 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-01-11 |
P860004-S421 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2024-01-10 |
P150033-S182 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2024-01-08 |
P960009-S438 |
Master Activa®, Percept and SenSight Deep Brain Stimulation Therapy System |
Normal 180 Day Track |
MBX |
— |
— |
| 2024-01-08 |
P170006-S024 |
Avalus Bioprosthesis |
Normal 180 Day Track |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-12-29 |
P960009-S468 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-12-23 |
P130021-S151 |
Medtronic CoreValve System, Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2023-12-15 |
P980035-S768 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-12-15 |
P860004-S420 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-12-15 |
P220012-S009 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-13 |
P980035-S767 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-12-13 |
P950024-S110 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-12-13 |
P930039-S256 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-12-13 |
P920015-S283 |
DF-1 Connector Port Pin Plug, HV Splitter/Adopter Kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-12-13 |
P230017 |
PulseSelect Pulsed Field Ablation (PFA) system |
Original |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2023-12-13 |
P220012-S008 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-13 |
P220012-S005 |
Lead EV ICD Extravascular - Epsila |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-13 |
P150033-S181 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-12-13 |
P120017-S035 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2023-12-13 |
P090013-S330 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-12-13 |
P080006-S182 |
Attain Ability Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-12-13 |
P010015-S529 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-12-12 |
P960009-S462 |
Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-12-12 |
P860004-S416 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-12-10 |
P220012-S010 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-07 |
P980035-S764 |
Astra S DR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG,Azure S SR MRI IPG, Azure XT DR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-12-07 |
P220012-S003 |
EV ICD - Aurora |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-07 |
P150033-S180 |
MicraAVTPS, Miera TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-12-07 |
P010015-S527 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-12-01 |
P980035-S765 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-11-30 |
P200046-S026 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-11-29 |
P980035-S766 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-11-29 |
P960009-S466 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-11-29 |
P960009-S461 |
MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-11-29 |
P920015-S284 |
HV Splitter/Adaptor kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-11-29 |
P220012-S007 |
Lead EV ICD Extravascular - Epsila |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-29 |
P220012-S006 |
Aurora EV ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-29 |
P220012-S004 |
EV ICD - Aurora |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-29 |
P010015-S528 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRTP, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solar |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-11-28 |
P990064-S087 |
Mosaic Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2023-11-28 |
P980043-S078 |
Hancock II Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2023-11-28 |
P970031-S072 |
Freestyle Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-11-28 |
P860004-S419 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-11-28 |
P860004-S415 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-11-28 |
P170006-S030 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-11-20 |
P980035-S762 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-11-20 |
P220012-S002 |
EV ICD - Aurora |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-17 |
P220026 |
Symplicity Spyral Renal Denervation System |
Original |
QYI |
Ablation Catheter, Renal Denervation |
Unknown |
| 2023-11-17 |
P080006-S180 |
Attain Performa Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-11-13 |
P920015-S281 |
HV Splitter/Adaptor kit |
Real-Time Process |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-11-09 |
P860004-S418 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-11-08 |
P980035-S763 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-11-08 |
P080006-S181 |
Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-11-07 |
P130021-S150 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo Pro Delivery Catheter System, Evolut PRO+ Delivery Catheter |
30-Day Notice |
NPT |
— |
— |
| 2023-11-03 |
P980050-S142 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-03 |
P980035-S761 |
Adapta, Versa, Sensia IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MRI |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-11-03 |
P950024-S109 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-11-03 |
P930039-S255 |
CapSureFix Lead, CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-11-03 |
P920015-S282 |
Sprint Quattro Lead, Subcutaneous Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-11-03 |
P890003-S464 |
CapSure VDD-2 Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-11-03 |
P200046-S023 |
Harmony TPV System |
Normal 180 Day Track No User Fee |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-11-03 |
P120017-S034 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2023-11-03 |
P080006-S179 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-11-03 |
P060039-S115 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-11-03 |
P010015-S526 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-11-02 |
P220012-S001 |
EV ICD Aurora |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-01 |
P200046-S025 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-11-01 |
P200046-S024 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-11-01 |
P130021-S149 |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtroni |
30-Day Notice |
NPT |
— |
— |
| 2023-11-01 |
P130021-S148 |
Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medtronic Evolut PRO+ Transcatheter Aortic Valve, Medtroni |
30-Day Notice |
NPT |
— |
— |
| 2023-10-27 |
P990064-S086 |
Mosaic Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2023-10-27 |
P980043-S077 |
Hancock II Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2023-10-27 |
P970031-S071 |
Freestyle Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-10-27 |
P870078-S050 |
Hancock Valved Conduit |
30-Day Notice |
DYE |
— |
— |
| 2023-10-27 |
P170006-S028 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-10-26 |
P920015-S277 |
Tunneling Tool |
Normal 180 Day Track No User Fee |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-10-20 |
P220012 |
Aurora EV-ICD System |
Original |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-10-19 |
P960009-S465 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-10-19 |
P150033-S179 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-10-18 |
P980035-S760 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-10-18 |
P960009-S464 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-10-18 |
P860004-S417 |
SynchroMed® Infusion System, Ascenda ® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-10-18 |
P150033-S178 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-10-18 |
P100047-S214 |
HeartWare HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2023-10-18 |
P010015-S525 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-10-12 |
P960009-S463 |
Activa® Deep Brain Stimulation Therapy System, Percept BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-10-12 |
P200046-S022 |
Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-10-12 |
P200028-S022 |
DiamondTemp Catheter, Unidirectional, Small Curve, DiamondTemp Catheter, Unidirectional, Large Curve, DiamondTemp Cathet |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-10-12 |
P150033-S177 |
Micra AV Transcatheter Pacing System, Micra Transcatheter Pacing System, Micra VR Transcatheter Pacing System |
30-Day Notice |
PNJ |
— |
— |
| 2023-10-12 |
P140010-S076 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-10-12 |
P130021-S147 |
CoreValve EnVeo Pro Delivery Catheter System, CoreValve EnVeo Pro Loading System, Evolut PRO+ Delivery Catheter System, |
30-Day Notice |
NPT |
— |
— |
| 2023-10-10 |
P960009-S455 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-10-06 |
P990034-S044 |
IsoMed Infusion System |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-10-06 |
P860004-S404 |
SynchroMed III Pump |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-10-06 |
P050053-S062 |
INFUSE Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2023-09-26 |
P960009-S460 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-09-26 |
P860004-S406 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-09-25 |
P200046-S021 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-09-25 |
P170006-S027 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-09-25 |
P140017-S025 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-09-25 |
P130021-S146 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2023-09-22 |
P960009-S445 |
Percept PC INS with BrainSense (Model B35200) |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-09-22 |
P140010-S074 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Normal 180 Day Track No User Fee |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-09-19 |
P200046-S020 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
— |
— |
— |
| 2023-09-19 |
P170006-S026 |
Medtronic Avalus Bioprosthesis, Model 400 |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-09-19 |
P130021-S145 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2023-09-11 |
P200046-S019 |
Harmony Transcatheter Pulmonic Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-09-05 |
P980035-S759 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-09-05 |
P960009-S459 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-08-30 |
P980035-S758 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Azure S DR MR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-08-30 |
P140010-S075 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter, IN.PACT 018 Paclitaxel-C |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-08-30 |
P130021-S143 |
Medtronic CoreValve TM EvolutTM R Transcatheter Aortic Valve, Medtronic CoreValveTM EvolutTM PRO Transcatheter Aortic V |
30-Day Notice |
NPT |
— |
— |
| 2023-08-25 |
P130021-S144 |
Evolut FX Delivery Catheter System of the Medtronic Evolut FX System |
30-Day Notice |
NPT |
— |
— |
| 2023-08-22 |
P170006-S023 |
Medtronic Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-08-21 |
P050053-S061 |
INFUSE Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2023-08-21 |
P050053-S060 |
INFUSE Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2023-08-20 |
P100047-S211 |
HeartWare Ventricular Assist System or HeartWare System |
Real-Time Process |
DSQ |
— |
— |
| 2023-08-10 |
P990064-S085 |
Mosaic Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2023-08-10 |
P980043-S076 |
Freestyle Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2023-08-10 |
P970031-S070 |
Hancock II Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-08-10 |
P960009-S458 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-08-10 |
P960009-S457 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-08-10 |
P860004-S414 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-08-10 |
P200046-S018 |
Harmony Transcatheter Pulmonic Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-08-10 |
P170006-S022 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-08-09 |
P980035-S755 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-08-03 |
P980035-S756 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-08-03 |
P960009-S456 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-08-03 |
P860004-S413 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-08-01 |
P980050-S141 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-08-01 |
P980035-S757 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-08-01 |
P950024-S108 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-08-01 |
P930039-S254 |
CapSureFix Novus Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-08-01 |
P920015-S280 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, Lead Adaptor, Sprint Quattro Lead, Subcut |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-08-01 |
P130021-S142 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve System, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valv |
30-Day Notice |
NPT |
— |
— |
| 2023-08-01 |
P120017-S033 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2023-08-01 |
P090013-S329 |
CapSureFix MRI Lead |
30-Day Notice |
— |
— |
— |
| 2023-08-01 |
P080006-S178 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-08-01 |
P060039-S114 |
ATTAIN STARFIX MODEL 4195 LEAD |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-08-01 |
P010015-S524 |
Attain Bipolar OTW Lead, Attain OTW L V Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CR T-P, Seren |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-07-28 |
P130021-S140 |
Medtronic Evolut R Transcatheter Aortic Valve Replacement System, Medtronic Evolut PRO Transcatheter Aortic Valve Replac |
30-Day Notice |
NPT |
— |
— |
| 2023-07-27 |
P140017-S024 |
Melody Transcatheter Pulmonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-07-26 |
P890003-S462 |
Adaptor Assembly Cable, Analzer Cable, CareLink Encore Programmer, CareLink SmartSync Device Manager Patient Connector, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-07-25 |
P130021-S141 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2023-07-21 |
P200028-S020 |
DiamondTemp Unidirectional Ablation Catheter, Small Curve, DiamondTemp Unidirectional Ablation Catheter, Large Curve, |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-07-20 |
P960009-S454 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-07-19 |
P200028-S021 |
DiamondTemp Ablation System |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-07-17 |
P980035-S753 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-07-17 |
P150033-S175 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-07-17 |
P010015-S523 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-07-14 |
P860004-S408 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-07-13 |
P980035-S754 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-07-13 |
P010015-S522 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-07-11 |
P950024-S107 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-07-11 |
P930039-S253 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-07-11 |
P920015-S279 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-07-11 |
P890003-S463 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-07-11 |
P150033-S176 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-07-11 |
P090013-S328 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-07-11 |
P080006-S177 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead, |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-07-07 |
P100047-S212 |
HeartWare® Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-07-03 |
P980035-S752 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-06-21 |
P960009-S453 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-06-21 |
P860004-S412 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-06-21 |
P200028-S018 |
DiamondTemp Irrigation Tubing Set |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-06-21 |
P100047-S210 |
HeartWare® Ventricular Assist System, HeartWare® System |
30-Day Notice |
DSQ |
— |
— |
| 2023-06-20 |
P980035-S749 |
Adapta, Versa, Sensia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-06-14 |
P980050-S140 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-06-14 |
P980035-S751 |
Adapta, Versa, Sensia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-06-14 |
P950024-S106 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-06-14 |
P930039-S252 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-06-14 |
P920015-S278 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Ad |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-06-14 |
P890003-S461 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-06-14 |
P150033-S174 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-06-14 |
P120017-S032 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2023-06-14 |
P090013-S327 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-06-14 |
P080006-S176 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
— |
— |
— |
| 2023-06-14 |
P010015-S521 |
Attain Bipolar OTW Lead, OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-06-13 |
P980035-S748 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-06-13 |
P200046-S017 |
Harmony TPV |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-06-13 |
P150033-S172 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-06-13 |
P130021-S139 |
Evolut R TAV, Evolut PRO TAV, Evolut PRO+ TAV, Evolut FX TAV |
30-Day Notice |
NPT |
— |
— |
| 2023-06-13 |
P010015-S519 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-06-12 |
P980035-S747 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-06-12 |
P010015-S518 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-06-09 |
P980035-S750 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-06-09 |
P150033-S173 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-06-09 |
P010015-S520 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-06-07 |
P860004-S411 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-06-07 |
P860004-S410 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-06-07 |
P150033-S166 |
Micra AV TPS, Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2023-06-02 |
P960009-S452 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-06-02 |
P860004-S409 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-06-02 |
P130021-S138 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath |
30-Day Notice |
NPT |
— |
— |
| 2023-05-26 |
P930039-S250 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
Real-Time Process |
NVN |
— |
— |
| 2023-05-24 |
P200028-S017 |
Loctite® 4206 |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-05-23 |
P980035-S746 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-05-23 |
P930039-S251 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-05-23 |
P200046-S016 |
Harmony Transcatheter Pulmonic Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-05-22 |
P140010-S073 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-05-17 |
P920015-S276 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-05-16 |
P890003-S460 |
OUS HeartTone MRI Application Software |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-05-09 |
P150033-S171 |
Micra AV H3, Micra Scalable, Micra AV TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-05-09 |
P150033-S170 |
Micra AV TPS, Micra TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-05-04 |
P960009-S451 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-05-04 |
P860004-S407 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-05-04 |
P150033-S169 |
Micra AV TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-05-04 |
P150033-S168 |
Micra AV TPS, Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-05-04 |
P140010-S072 |
IN.PACT Admiral DCB |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2023-04-28 |
P130021-S137 |
Medtronic Core Valve Evolut R Transcatheter Aortic Valve, Medtronic Core Valve Evolut Pro Transcatheter Aortic Valve |
30-Day Notice |
NPT |
— |
— |
| 2023-04-26 |
P980035-S744 |
Adapta, Versa, Sensia IPG, Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-04-26 |
P130021-S133 |
Medtronic CoreValve EnVeo PRO Loading System, Medtronic Evolut PRO+ Loading System, Medtronic Evolut FX Loading Syst |
30-Day Notice |
NPT |
— |
— |
| 2023-04-26 |
P100047-S209 |
HeartWare® Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-04-25 |
P130021-S134 |
Medtronic Evolut FX Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2023-04-20 |
P960009-S450 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-04-20 |
P890003-S457 |
CareLink Instruments & DDMA, CareLink SmartSync Common Application |
Normal 180 Day Track |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-04-20 |
P150033-S161 |
Micra VR2 Transcatheter Pacing System, Micra AV2 Transcatheter Pacing System, Micra VR2/AV2 Application Software |
Normal 180 Day Track |
PNJ |
— |
— |
| 2023-04-19 |
P130021-S136 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath |
30-Day Notice |
NPT |
— |
— |
| 2023-04-13 |
P130021-S135 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2023-04-12 |
P980035-S743 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-04-12 |
P150033-S167 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-04-12 |
P010015-S517 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-04-07 |
P010015-S516 |
Consulta CRT-P, Syncra CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-03-22 |
P150033-S153 |
Micra AV TPS, Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2023-03-21 |
P130021-S132 |
Medtronic Evolut PRO+ System and Medtronic Evolut FX System |
Special (Immediate Track) |
NPT |
— |
— |
| 2023-03-17 |
P960009-S447 |
Deep Brain Stimulation (DBS) Accessories |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-03-17 |
P080006-S175 |
Attain Stability Quad MRI Surescan |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-03-16 |
P960009-S448 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-03-14 |
P960009-S418 |
Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-03-14 |
P860004-S385 |
SynchroMed® Infusion System |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-03-13 |
P200028-S016 |
DiamondTemp Ablation System |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-03-10 |
P960009-S449 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MBX |
— |
— |
| 2023-03-09 |
P980035-S742 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-03-09 |
P930039-S249 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-03-09 |
P860004-S405 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2023-03-09 |
P090013-S326 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-03-08 |
P100047-S206 |
HeartWare Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2023-03-03 |
P100047-S208 |
Pioneer 2.0 HVAD Controller |
30-Day Notice |
DSQ |
— |
— |
| 2023-03-01 |
P200028-S015 |
DiamondTemp Ablation System |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-03-01 |
P150033-S165 |
Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2023-02-17 |
P920015-S275 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-02-16 |
P980035-S741 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-02-15 |
P200046-S014 |
Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-02-15 |
P100047-S207 |
HeartWare HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2023-02-13 |
P100047-S204 |
HeartWare Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2023-02-12 |
P200046-S015 |
Harmony Transcatheter Pulmonary Valve, Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2023-02-08 |
P890003-S459 |
Instrument Command Library (ICL), Device Command Library (DCL) |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-02-06 |
P980035-S740 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-02-06 |
P080006-S174 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-02-06 |
P060039-S113 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2023-02-06 |
P010015-S515 |
Attain Bipolar OTW Lead, Attain OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-02-06 |
P010015-S514 |
Consulta CRT-P, Percepta Bioplar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-02-03 |
P980035-S739 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-02-03 |
P010015-S513 |
Consulta CRT-P, Syncra CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-02-02 |
P960009-S446 |
Activa® Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-02-02 |
P100047-S205 |
HeartWare® Ventricular Assist System, HeartWare® System |
30-Day Notice |
DSQ |
— |
— |
| 2023-02-01 |
P130021-S130 |
Medtronic CoreValue Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt |
30-Day Notice |
NPT |
— |
— |
| 2023-01-29 |
P130021-S131 |
Evolut FX Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2023-01-18 |
P150033-S162 |
CareLink SmartSync Micra VR App, CareLink SmartSync Micra AV App |
Real-Time Process |
OSR |
Pacemaker/Icd/Crt Non-Implanted Components |
Unknown |
| 2023-01-17 |
P980035-S738 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-01-17 |
P010015-S512 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-01-16 |
P980035-S737 |
Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2023-01-16 |
P930039-S248 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2023-01-16 |
P920015-S274 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2023-01-04 |
P980035-S736 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-12-13 |
P200028-S013 |
DiamondTemp Ablation System |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2022-12-12 |
P150033-S164 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-12-08 |
P960009-S444 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-12-08 |
P860004-S403 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-12-08 |
P120010-S142 |
MiniMed Enlite Sensor |
30-Day Notice |
OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
| 2022-12-02 |
P860004-S402 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-12-01 |
P200046-S013 |
Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-12-01 |
P140010-S071 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-12-01 |
P130021-S129 |
Medtronic CoreValve Evolut FX System |
30-Day Notice |
NPT |
— |
— |
| 2022-12-01 |
P130021-S128 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst |
30-Day Notice |
NPT |
— |
— |
| 2022-11-28 |
P150033-S163 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-11-28 |
P140017-S023 |
Medtronic Melody Transcatheter Pulmonic Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-11-28 |
P130021-S127 |
Medtronic CoreValve0153 Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System and Med |
30-Day Notice |
NPT |
— |
— |
| 2022-11-22 |
P980050-S139 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-11-22 |
P980035-S735 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-11-22 |
P980035-S734 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-11-22 |
P960009-S443 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-11-22 |
P960009-S442 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-11-22 |
P950024-S105 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-11-22 |
P930039-S247 |
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-11-22 |
P920015-S273 |
HV Splitter/Adaptor Kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-11-22 |
P890003-S458 |
CapSure VDD-2 Lead and Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-11-22 |
P090013-S325 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-11-22 |
P080006-S173 |
Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-11-22 |
P060039-S112 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-11-22 |
P010015-S511 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-11-22 |
P010015-S510 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-11-18 |
P980035-S733 |
Adapta, Versa, Sensia IPG, Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-11-16 |
P960009-S441 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-11-16 |
P200028-S014 |
DIAMOND AF |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2022-11-15 |
P150033-S159 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-11-14 |
P860004-S401 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-11-14 |
P150033-S158 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-11-11 |
P150033-S160 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-11-04 |
P150033-S155 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-11-03 |
P150033-S156 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-11-03 |
P130021-S123 |
Medtronic CoreValve Evolut R DCS (EnVeo R DCS), Medtronic CoreValve Evolut PRO DCS (EnVeo PRO DCS), Medtronic Evolut |
30-Day Notice |
NPT |
— |
— |
| 2022-11-01 |
P200046-S012 |
Harmony Delivery Catheter System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-11-01 |
P150033-S157 |
Micra |
30-Day Notice |
PNJ |
— |
— |
| 2022-11-01 |
P140010-S070 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter, IN.PACT 018 Paclitaxel-Coated |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-11-01 |
P130021-S126 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst |
30-Day Notice |
NPT |
— |
— |
| 2022-11-01 |
P130021-S125 |
Medtronic Evolut PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery Catheter System, Medtronic Evolut FX Deliv |
30-Day Notice |
NPT |
— |
— |
| 2022-10-31 |
P100047-S202 |
HeartWare® Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-10-26 |
P860004-S400 |
SynchroMed® Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-10-25 |
P980035-S732 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-10-25 |
P980035-S731 |
Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-10-25 |
P930039-S246 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-10-25 |
P920015-S272 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-10-25 |
P010015-S509 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-10-21 |
P960009-S440 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-10-20 |
P010015-S508 |
Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-10-16 |
P980035-S723 |
Advisa DR MRI IPG, Advisa SR MRI IPG |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-10-16 |
P890003-S455 |
CareLink SmartSync Platform, CareLink SmartSync MRI Host Application, CareLink SmartSync Common Application and Patient |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-10-16 |
P150033-S145 |
Micra TPS, Micra AV TPS |
Real-Time Process |
PNJ |
— |
— |
| 2022-10-14 |
P010015-S507 |
Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-10-12 |
P200028-S012 |
DiamondTemp Ablation System with the EnSite X Mapping System |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2022-10-12 |
P150033-S154 |
Micra Transcatheter Pacing System, Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-10-11 |
P140010-S068 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter and 3 IN.PACT 018 Paclita |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-10-06 |
P890003-S456 |
CareLink SmartSync Platform, CareLink SmartSync MRI Host Application, CareLink SmartSync Common Application, CareLink Sm |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-10-04 |
P960009-S439 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-10-04 |
P130021-S120 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2022-09-30 |
P100047-S196 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2022-09-28 |
P860004-S399 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-09-27 |
P130021-S122 |
EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2022-09-22 |
P860004-S398 |
SynchroMed® Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-09-21 |
P980035-S729 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-09-21 |
P010015-S506 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-09-16 |
P990034-S043 |
IsoMed Infusion System |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-09-16 |
P980035-S728 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-09-16 |
P860004-S397 |
Master SynchroMed II Infusion System |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-09-16 |
P150033-S152 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-09-15 |
P980035-S730 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-09-15 |
P930039-S245 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-09-15 |
P920015-S271 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-09-15 |
P150033-S151 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-09-15 |
P090013-S324 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-09-09 |
P130021-S121 |
Medtronic Evolut FX Delivery Catheter and Loading Systems |
30-Day Notice |
NPT |
— |
— |
| 2022-09-08 |
P860004-S396 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-09-08 |
P100047-S200 |
HeartWare HVAD System |
Normal 180 Day Track No User Fee |
DSQ |
— |
— |
| 2022-09-07 |
P960009-S437 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MBX |
— |
— |
| 2022-09-06 |
P150033-S150 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-09-02 |
P860004-S387 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-09-02 |
P140010-S067 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-08-26 |
P980035-S727 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-08-26 |
P980035-S721 |
Advisa DR MRI SureScan Model A2DR01 IPG, Advisa SR MRI SureScan Model A3SR01 IPG |
Normal 180 Day Track No User Fee |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-08-26 |
P960009-S436 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-08-26 |
P930039-S244 |
CapSureFix Novus MRI SureScan Lead Models 4076 and 5076 |
Normal 180 Day Track No User Fee |
NVN |
— |
— |
| 2022-08-26 |
P920015-S270 |
Sprint Quattro Secure MRI SureScan Model 6947M lead, Sprint Quattro Secure S MRI SureScan Model 6935M lead |
Normal 180 Day Track No User Fee |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-08-26 |
P090013-S323 |
CapSureFix MRI SureScan Lead Model 5086MRI |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-08-26 |
P010015-S505 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Solara Bipolar CRT-P, Solara Q |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-08-23 |
P980035-S726 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-08-19 |
P990034-S042 |
IsoMed Infusion System |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-08-19 |
P860004-S395 |
SynchroMed Infusion System |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-08-16 |
P150033-S149 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-08-10 |
P960009-S434 |
Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
— |
— |
— |
| 2022-08-09 |
P980035-S725 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-08-09 |
P050053-S059 |
Infuse Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2022-08-09 |
P010015-S504 |
Consulta CRT-P, Syncra CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-08-03 |
P960009-S433 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-08-03 |
P200046-S010 |
Medtronic Harmony Transcatheter Pulmonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-08-03 |
P170006-S021 |
Avalus |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-08-03 |
P140017-S022 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-08-03 |
P130021-S119 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System |
30-Day Notice |
NPT |
— |
— |
| 2022-07-28 |
P960009-S435 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-07-28 |
P860004-S394 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-07-27 |
P200046-S011 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-07-27 |
P150033-S148 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-07-26 |
P150033-S147 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-07-25 |
P980035-S724 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-07-25 |
P150033-S146 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-07-25 |
P010015-S503 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-19 |
P980035-S722 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-07-19 |
P010015-S502 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-15 |
P150033-S144 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-07-15 |
P150033-S098 |
Micra Transcatheter Pacemaker System |
135 Review Track For 30-Day Notice |
PNJ |
— |
— |
| 2022-07-15 |
P130021-S088 |
EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P |
135 Review Track For 30-Day Notice |
NPT |
— |
— |
| 2022-07-08 |
P140010-S066 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-07-08 |
P130021-S115 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut Pro System, Medtronic Evolut Pro+ System, Medtronic Evol |
Real-Time Process |
NPT |
— |
— |
| 2022-07-07 |
P130021-S118 |
Medtronic EnVeo R Delivery Catheter System, Medtronic EnVeo PRO Delivery Catheter System, Medtronic Evolut PRO+ Delivery |
30-Day Notice |
NPT |
— |
— |
| 2022-06-30 |
P150033-S143 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-06-28 |
P100047-S201 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-06-24 |
P100047-S199 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-06-22 |
P150033-S142 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-06-21 |
P140010-S064 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-06-16 |
P100047-S198 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-06-15 |
P960009-S424 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-06-15 |
P200028-S011 |
DiamondTemp Ablation Catheters |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2022-06-09 |
P990034-S041 |
IsoMed Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-06-09 |
P960009-S430 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-06-09 |
P860004-S392 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-06-09 |
P050053-S058 |
Infuse Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2022-06-08 |
P130021-S117 |
Medtronic Evolut FX Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2022-06-07 |
P980035-S720 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-06-02 |
P960009-S432 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-06-01 |
P980050-S138 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-06-01 |
P980035-S719 |
Adapta, Versa, Sensia IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta DR/SR MRI IPG, Azure S DR/SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-06-01 |
P980035-S718 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-06-01 |
P960009-S431 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-06-01 |
P950024-S104 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-06-01 |
P930039-S243 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-06-01 |
P930029-S071 |
RF Conductr, RF Enhancr II, RF Marinr, RF Unipolar Marinr |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-06-01 |
P920015-S269 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead A |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-06-01 |
P890003-S454 |
CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-06-01 |
P860004-S393 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-06-01 |
P150033-S141 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-06-01 |
P120017-S031 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2022-06-01 |
P090013-S322 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-06-01 |
P080006-S172 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-06-01 |
P060039-S111 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-06-01 |
P010015-S501 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-06-01 |
P010015-S500 |
Attain Bipolar OTW Lead,Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena B |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-05-25 |
P960009-S429 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-05-24 |
P960009-S428 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-05-24 |
P960009-S427 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-05-23 |
P200046-S009 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-05-23 |
P130021-S116 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut PRO Transcatheter Aortic Valve, Medt |
30-Day Notice |
NPT |
— |
— |
| 2022-05-18 |
P100047-S184 |
HeartWare Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2022-05-17 |
P980035-S717 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-05-17 |
P150033-S140 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-05-17 |
P010015-S499 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-05-12 |
P960009-S426 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-05-12 |
P860004-S391 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-05-11 |
P930039-S242 |
CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-05-11 |
P090013-S321 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-05-10 |
P980035-S715 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-05-10 |
P960009-S425 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-05-10 |
P860004-S390 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-05-10 |
P100047-S197 |
HeartWare® Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-05-05 |
P860004-S389 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-05-03 |
P980035-S714 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-05-03 |
P920015-S268 |
HV Splitter/Adaptor kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-05-03 |
P150033-S138 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-05-03 |
P080006-S171 |
Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-05-03 |
P010015-S497 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-05-02 |
P200028-S009 |
DiamondTemp Ablation System |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2022-04-29 |
P130021-S109 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System, Medtronic Evol |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2022-04-29 |
P120010-S141 |
Enlite Sensor (MMT-7008) |
30-Day Notice |
OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
| 2022-04-28 |
P890003-S453 |
Patient Connector |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-04-26 |
P980035-S713 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-04-26 |
P150033-S137 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-04-26 |
P010015-S496 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-04-21 |
P980050-S137 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-04-21 |
P980035-S712 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-04-21 |
P950024-S103 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-04-21 |
P930039-S241 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-04-21 |
P920015-S267 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-04-21 |
P890003-S452 |
CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-04-21 |
P150033-S136 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-04-21 |
P120017-S030 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2022-04-21 |
P090013-S320 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-04-21 |
P080006-S170 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-04-21 |
P060039-S110 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-04-21 |
P010015-S495 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-04-19 |
P130021-S113 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Cath |
30-Day Notice |
NPT |
— |
— |
| 2022-04-08 |
P200046-S008 |
Harmony Transcatheter Pulmonary Valve |
Normal 180 Day Track No User Fee |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-04-07 |
P140010-S062 |
IN.PACT 018 Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Normal 180 Day Track |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-04-06 |
P960009-S419 |
Master Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-03-31 |
P130021-S114 |
EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, Evolut FX De |
30-Day Notice |
NPT |
— |
— |
| 2022-03-30 |
P960009-S423 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-03-30 |
P860004-S388 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-03-29 |
P980035-S711 |
Adapta, Versa, Sensia, Astra S DR MRI IPG, Astra S SR MRI IPG,Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR MRI I |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-03-29 |
P930039-S240 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-03-25 |
P960009-S422 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-03-24 |
P980035-S710 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-03-24 |
P130021-S111 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt |
Special (Immediate Track) |
NPT |
— |
— |
| 2022-03-24 |
P010015-S494 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-03-23 |
P980035-S709 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-03-23 |
P980035-S708 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-03-23 |
P010015-S493 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-03-21 |
P130021-S112 |
Medtronic CoreValve EnVeo R Loading System, Medtronic CoreValve EnVeo Pro Loading System, Medtronic Evolut Pro+ Loa |
30-Day Notice |
NPT |
— |
— |
| 2022-03-18 |
P960009-S417 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-03-18 |
P860004-S384 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-03-17 |
P200028-S008 |
DiamondTemp Radiofrequency Generator |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2022-03-16 |
P960009-S409 |
Activa® Deep Brain Stimulation Therapy System. |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-03-16 |
P860004-S379 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters. |
135 Review Track For 30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-03-16 |
P100047-S195 |
HeartWare Ventricular Assist (HVAD) System |
Special (Immediate Track) |
DSQ |
— |
— |
| 2022-03-15 |
P980035-S706 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-03-15 |
P100047-S194 |
Heartware Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-03-14 |
P930039-S238 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-03-14 |
P080006-S169 |
Attain Stability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-03-11 |
P100047-S193 |
HeartWare® HVAD System |
Special (Immediate Track) |
DSQ |
— |
— |
| 2022-03-08 |
P980035-S707 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-03-04 |
P200028-S010 |
DiamondTemp Ablation Catheters |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2022-03-02 |
P980035-S703 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-03-02 |
P920015-S265 |
Sorint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-03-01 |
P200046-S007 |
Harmony Transcatheter Pulmonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-03-01 |
P170006-S020 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-03-01 |
P140017-S021 |
Melody Transcatheter Pulmonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-03-01 |
P130021-S110 |
Evolut R Transcatheter Aortic Valve System, Evolut PRO Transcatheter Aortic Valve System, Evolut PRO+ Transcatheter Aort |
30-Day Notice |
NPT |
— |
— |
| 2022-03-01 |
P100047-S192 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-02-28 |
P980035-S704 |
Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-02-28 |
P930039-S239 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-02-28 |
P920015-S266 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-02-26 |
P960009-S420 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-02-26 |
P860004-S386 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-02-25 |
P980035-S705 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-02-25 |
P960009-S421 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-02-25 |
P930039-S237 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-02-25 |
P150033-S135 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-02-25 |
P150033-S134 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-02-25 |
P010015-S492 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-02-22 |
P990064-S077 |
Mosaic Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2022-02-22 |
P980043-S069 |
Hancock II Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2022-02-22 |
P970031-S064 |
Freestyle Bioprosthesis |
135 Review Track For 30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-02-22 |
P870078-S044 |
Hancock Valved Conduit LP |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2022-02-22 |
P170006-S007 |
Avalus Bioprosthesis |
135 Review Track For 30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-02-22 |
P140017-S013 |
Melody TPV |
135 Review Track For 30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-02-22 |
P130021-S056 |
CoreValve TAV, Evolut-R TAV, Evolut PRO TAV |
135 Review Track For 30-Day Notice |
NPT |
— |
— |
| 2022-02-18 |
P960009-S408 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-02-18 |
P860004-S378 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2022-02-18 |
P050053-S057 |
INFUSE Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2022-02-18 |
P050053-S053 |
Infuse Bone Graft |
Normal 180 Day Track |
NPZ |
— |
— |
| 2022-02-09 |
P130021-S108 |
CoreValve Evolut R Delivery Catheter System, CoreValve Evolut Pro Delivery Catheter System, Evolut Pro+ Delivery Ca |
30-Day Notice |
NPT |
— |
— |
| 2022-02-02 |
P140017-S020 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-02-01 |
P960009-S415 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-02-01 |
P150033-S133 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-01-28 |
P980035-S702 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-01-28 |
P950024-S102 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-01-28 |
P930039-S236 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2022-01-28 |
P920015-S264 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2022-01-28 |
P890003-S451 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-01-28 |
P150033-S132 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-01-28 |
P090013-S319 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-01-28 |
P080006-S168 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2022-01-28 |
P010015-S491 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-01-28 |
P010015-S490 |
Attain Bipolar OTW Lead, Attain OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-01-27 |
P200046-S003 |
Harmony Delivery Catheter System (DCS) and Loading System |
135 Review Track For 30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2022-01-27 |
P150033-S107 |
Micra Transcatheter Pacemaker System |
135 Review Track For 30-Day Notice |
PNJ |
— |
— |
| 2022-01-27 |
P140010-S061 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2022-01-27 |
P130021-S095 |
EnVeo PRO Delivery Catheter System (DCS) and Loading System, EnVeo R Delivery Catheter System & Loading System, Evolut P |
135 Review Track For 30-Day Notice |
NPT |
— |
— |
| 2022-01-21 |
P980035-S701 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-01-21 |
P150033-S131 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-01-21 |
P010015-S489 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-01-19 |
P960009-S416 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-01-18 |
P980035-S700 |
Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S DR/SR MRI IPG and Azure XT DR/SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-01-18 |
P150033-S130 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2022-01-12 |
P980035-S694 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-01-10 |
P980035-S699 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2022-01-10 |
P010015-S488 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-21 |
P860004-S380 |
SynchroMed® Infusion System |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-12-17 |
P980035-S698 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-12-17 |
P140010-S053 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-12-17 |
P120010-S140 |
MiniMed 530G System |
Special (Immediate Track) |
OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
| 2021-12-17 |
P080006-S167 |
Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-12-16 |
P200046-S006 |
Harmony Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2021-12-16 |
P130021-S107 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt |
30-Day Notice |
NPT |
— |
— |
| 2021-12-15 |
P960009-S414 |
Activa® Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-12-15 |
P860004-S383 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-12-13 |
P920015-S263 |
HV Splitter/Adaptor kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-12-09 |
P980035-S697 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-12-09 |
P150033-S129 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-12-09 |
P140010-S063 |
IN.PACT® Admiral® Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-12-09 |
P010015-S487 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-07 |
P980050-S136 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-12-07 |
P980035-S696 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-12-07 |
P950024-S101 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-12-07 |
P930039-S234 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-12-07 |
P930029-S070 |
RF Conductr, RF Contactr, RF Enhancr II, RF Marinr, RF Unipolar Marinr |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2021-12-07 |
P920015-S261 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-12-07 |
P890003-S450 |
CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer, Service Kit-Pacemaker Repair Kit, Vitatron Brilliant S |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-12-07 |
P150033-S127 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-12-07 |
P120017-S029 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2021-12-07 |
P090013-S317 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-07 |
P080006-S165 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-12-07 |
P060039-S109 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-12-07 |
P010015-S486 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-12-03 |
P960009-S413 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-12-03 |
P860004-S382 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-12-01 |
P130021-S106 |
Medtronic CoreValve EnVeo R Delivery Catheter System, Medtronic CoreValve EnVeo Pro Delivery Catheter System, Medtro |
30-Day Notice |
NPT |
— |
— |
| 2021-11-30 |
P980035-S695 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-11-30 |
P010015-S485 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-11-24 |
P930039-S235 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-11-24 |
P920015-S262 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-11-24 |
P150033-S128 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-11-24 |
P090013-S318 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-11-24 |
P080006-S166 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-11-23 |
P100047-S191 |
HeartWare® Ventricular Assist System or HeartWare® System |
30-Day Notice |
DSQ |
— |
— |
| 2021-11-22 |
P150033-S126 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-11-22 |
P100047-S183 |
HeartWare Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2021-11-19 |
P960009-S411 |
SenSight Burr Hole Device, SenSight Burr Hole Device Kit |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-11-10 |
P980050-S135 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-11-10 |
P930039-S233 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-11-10 |
P920015-S260 |
Sprint Quattro Lead, Subcutaneous Lead, Transvene CS/SVC Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-11-10 |
P090013-S316 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-11-10 |
P080006-S164 |
Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-11-08 |
P050053-S051 |
Infuse Bone Graft |
135 Review Track For 30-Day Notice |
NPZ |
— |
— |
| 2021-11-05 |
P960009-S412 |
Activa® Deep Brain Stimulation Therapy System; Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-11-03 |
P890003-S448 |
Reveal LINQ Application Software |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-11-02 |
P200028-S002 |
DiamondTemp Ablation System |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-10-28 |
P860004-S381 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-10-27 |
P980035-S693 |
Adapta, Versa, Sensia IPG, Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-10-27 |
P960009-S410 |
SenSight Extension Kit |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-10-27 |
P200028-S007 |
DiamondTemp Ablation System |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-10-26 |
P150033-S121 |
Micra AV TPS; Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-10-21 |
P130021-S104 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, |
Special (Immediate Track) |
NPT |
— |
— |
| 2021-10-19 |
P950024-S100 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-10-19 |
P130021-S105 |
Medtronic Evolut Pro+ Transcatheter Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2021-10-19 |
P080006-S163 |
Attain Ability Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-10-18 |
P100047-S190 |
HeartWare® Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-10-15 |
P150033-S125 |
Micra AV TPS; Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-10-15 |
P100047-S189 |
HeartWare HVAD System |
Real-Time Process |
DSQ |
— |
— |
| 2021-10-14 |
P150033-S124 |
Micra AV TPS; Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-10-13 |
P150033-S123 |
Micra AV TPS; Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-10-13 |
P150033-S122 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-10-12 |
P860004-S377 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-10-01 |
P930039-S232 |
CapSureFix Novus Lead Models 4076 and 5076 |
30-Day Notice |
NVN |
— |
— |
| 2021-10-01 |
P930039-S231 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-10-01 |
P150033-S120 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-09-28 |
P150033-S119 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-09-24 |
P980035-S692 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-09-24 |
P130021-S102 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, Medtronic Evolut PRO+ System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2021-09-24 |
P010015-S484 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-23 |
P980035-S691 |
Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Versa, Sensia IPG, Adapta, Vers |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-09-23 |
P010015-S483 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sol |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-22 |
P130021-S103 |
Evolut FX device |
30-Day Notice |
NPT |
— |
— |
| 2021-09-17 |
P930039-S230 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-09-15 |
P920015-S256 |
Sprint Quattro Lead |
Normal 180 Day Track |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-09-15 |
P150033-S118 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-09-14 |
P100047-S173 |
HeartWare Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2021-09-09 |
P960009-S407 |
SenSight Directional Lead Kit |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-09-08 |
P980035-S690 |
Astra S DR MRI IPG,Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG,Azure S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-09-08 |
P010015-S482 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-01 |
P960009-S406 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-08-31 |
P140032-S074 |
Implantable System for Remodulin |
Normal 180 Day Track No User Fee |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-08-30 |
P960009-S396 |
Activa Deep Brain Stimulation Therapy System |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-08-30 |
P860004-S368 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
135 Review Track For 30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-08-20 |
P960009-S405 |
SenSight Directional Lead Kit, SenSight Extension Kit |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-08-19 |
P920015-S258 |
Sprint Quattro Lead, Y Adaptor/Extender |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-08-19 |
P920015-S257 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-08-17 |
P980050-S134 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-08-17 |
P980035-S689 |
Adapta, Versa, Sensia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-08-17 |
P950024-S099 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-08-17 |
P930039-S229 |
CapSureFix Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-08-17 |
P920015-S259 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Lead Ad |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-08-17 |
P890003-S447 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-08-17 |
P120017-S028 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2021-08-17 |
P080006-S162 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-08-17 |
P060039-S108 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-08-17 |
P010015-S481 |
Attain Bipolar OTW Lead, Attain OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-08-16 |
P980035-S684 |
CareLink SmartSync Azure Astra Application |
Normal 180 Day Track |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-08-16 |
P890003-S445 |
CareLink SmartSync Platform, CareLink SmartSync Common Application and CareLink SmartSync MRI Host Application |
Normal 180 Day Track |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-08-16 |
P010015-S475 |
CareLink SmartSync Percepta Serena Solara Application |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-08-13 |
P960009-S404 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-08-12 |
P980035-S688 |
Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI I |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-08-12 |
P130021-S094 |
Medtronic Evolut FX System |
Normal 180 Day Track |
NPT |
— |
— |
| 2021-08-12 |
P100047-S174 |
HeartWare HVAD System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2021-08-12 |
P010015-S480 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-08-12 |
P010015-S479 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-08-10 |
P130021-S097 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2021-08-10 |
P100047-S188 |
HeartWare HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2021-08-03 |
P140017-S019 |
Melody Transcatheter Pulmonary Valve |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2021-08-03 |
P100047-S186 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-07-29 |
P960009-S403 |
SenSight Diectional Lead Kit |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-07-22 |
P100047-S185 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-07-21 |
P960009-S402 |
Activa® Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-07-21 |
P860004-S376 |
SynchroMed® Infusion System, Ascenda® Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-07-21 |
P140032-S073 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-07-19 |
P200046-S005 |
Harmony Transcatheter Pulmonary Valve System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2021-07-19 |
P130021-S101 |
Medtronic CoreValve Evolut PRO System, Medtronic CoreValve Evolut PRO+ System |
30-Day Notice |
NPT |
— |
— |
| 2021-07-16 |
P150033-S116 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-07-14 |
P980035-S687 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-07-14 |
P150033-S115 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-07-14 |
P010015-S478 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-07-12 |
P130021-S100 |
Evolut PRO+ Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2021-07-09 |
P150033-S114 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-07-08 |
P150033-S113 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-07-07 |
P980035-S686 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-07-07 |
P200046-S004 |
Harmony TPV System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2021-07-01 |
P150033-S112 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-06-30 |
P960009-S400 |
Medtronic Deep Brain Stimulation Therapy System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-06-30 |
P130021-S098 |
EnVeo R Delivery Catheter System, EnVeo PRO Delivery Catheter System, Evolut PRO+ Delivery Catheter System |
30-Day Notice |
NPT |
— |
— |
| 2021-06-28 |
P100047-S178 |
HeartWare Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2021-06-25 |
P960009-S401 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-06-25 |
P860004-S375 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-06-25 |
P150033-S111 |
Micra VR TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-06-25 |
P140032-S072 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-06-23 |
P980050-S133 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-06-23 |
P930039-S228 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-06-23 |
P920015-S255 |
Sprint Quattro Lead, Subcutaneous Lead, Transvene CS/SVC Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-06-23 |
P890003-S446 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-06-23 |
P100047-S182 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-06-23 |
P090013-S315 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-06-23 |
P080006-S161 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-06-23 |
P060039-S107 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-06-23 |
P010015-S477 |
Attain Bipolar OTW Lead, Attain OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-06-21 |
P150033-S110 |
Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-06-21 |
P150033-S102 |
Micra AV TPS and Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2021-06-21 |
P100047-S181 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-06-17 |
P150033-S104 |
Micra AV TPS, Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2021-06-17 |
P130021-S096 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, |
30-Day Notice |
NPT |
— |
— |
| 2021-06-16 |
P980035-S683 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-06-16 |
P150033-S108 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-06-16 |
P010015-S474 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-06-09 |
P960009-S385 |
Percept and Activa Deep Brain Stimulation Therapy Systems |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-06-09 |
P100047-S180 |
HeartWare HVAD System |
Special (Immediate Track) |
DSQ |
— |
— |
| 2021-06-09 |
P100047-S177 |
HeartWare Left Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2021-06-04 |
P980035-S685 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-06-04 |
P150033-S109 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-06-04 |
P010015-S476 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bip |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-06-02 |
P930039-S227 |
CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-06-02 |
P860004-S374 |
SynchroMed Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-06-02 |
P200028-S005 |
DiamondTemp Ablation System |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-06-02 |
P140032-S071 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-05-28 |
P200028-S004 |
DiamondTemp Ablation System |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-05-27 |
P980035-S677 |
CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-05-27 |
P890003-S444 |
CareLink SmartSync Platform, CareLink SmartSync Host Application, CareLink SmartSync Common Application, CareLink SmartS |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-05-27 |
P150033-S106 |
Micra Transcatheter Pacing System, Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-05-27 |
P150033-S096 |
CareLink SmartSync Micra VR/AV Application |
Real-Time Process |
PNJ |
— |
— |
| 2021-05-27 |
P010015-S470 |
CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-05-26 |
P930039-S226 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-05-25 |
P960009-S391 |
Activa, Percept and SenSight Deep Brain Stimulation Therapy System |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-05-25 |
P200028-S003 |
DiamondTemp Radiofrequency (RF) Generator |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-05-24 |
P100047-S179 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-05-21 |
P980035-S682 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-05-21 |
P200046-S002 |
Harmony Transcatheter Pulmonary System |
Special (Immediate Track) |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2021-05-21 |
P150033-S105 |
Micra Transcatheter Pacemaker System, Micra Transcatheter Pacemaker System, Micra AV application software |
Special (Immediate Track) |
PNJ |
— |
— |
| 2021-05-21 |
P140010-S060 |
IN.PACT Admiral DCB Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
Special (Immediate Track) |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-05-21 |
P130021-S092 |
Structural Heart Delivery Catheter Systems & Loading systems |
Special (Immediate Track) |
NPT |
— |
— |
| 2021-05-19 |
P200028-S006 |
DiamondTemp Ablation Catheters |
Special (Immediate Track) |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-05-18 |
P980035-S681 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-05-18 |
P010015-S473 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-05-11 |
P130021-S090 |
EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems |
30-Day Notice |
NPT |
— |
— |
| 2021-05-07 |
P960009-S397 |
Medtronic Deep Brain Stimulation Therapy System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-05-05 |
P980035-S676 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-05-05 |
P890003-S443 |
MyCareLink Patient Monitor |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-05-05 |
P150033-S095 |
Micra AV TPS and Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2021-05-05 |
P010015-S469 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-05-04 |
P860004-S373 |
SynchroMed® Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-05-04 |
P140032-S070 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-05-03 |
P860004-S372 |
SynchroMed Infusion System, Ascenda® IntrathecaI Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-05-03 |
P140032-S069 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-04-29 |
P130021-S093 |
EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems |
30-Day Notice |
NPT |
— |
— |
| 2021-04-29 |
P130021-S091 |
Medtronic CoreValve Evolut R Transcatheter Aortic Valve, Medtronic CoreValve Evolut Pro Transcatheter Aortic Valve, Medt |
30-Day Notice |
NPT |
— |
— |
| 2021-04-27 |
P930039-S225 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-04-27 |
P140010-S059 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-04-15 |
P150033-S101 |
Micra Transcatheter Pacing System (TPS) |
30-Day Notice |
PNJ |
— |
— |
| 2021-04-14 |
P150033-S100 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-04-12 |
P980035-S679 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG. Astra XT DR/SR MRI IPG, Attesta D |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-04-12 |
P010015-S472 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Biplar CRT-P, Serena Quadripolar CRT-P, Solar |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-06 |
P960009-S399 |
Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-04-06 |
P200046-S001 |
Harmony TPV System |
30-Day Notice |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2021-04-06 |
P050053-S056 |
INFUSE Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2021-04-02 |
P150033-S103 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-04-01 |
P860004-S371 |
SynchroMed Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-04-01 |
P140032-S068 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-04-01 |
P010015-S463 |
Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-03-31 |
P960009-S398 |
Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-03-31 |
P860004-S370 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-03-30 |
P100047-S176 |
HeartWare HVAD System |
Special (Immediate Track) |
DSQ |
— |
— |
| 2021-03-29 |
P980035-S680 |
Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-03-29 |
P930039-S224 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-03-29 |
P920015-S254 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-03-26 |
P200046 |
Harmony TPV System |
Original |
NPV |
Pulmonary Valve Prosthesis Percutaneously Delivered |
Unknown |
| 2021-03-26 |
P150033-S099 |
Micra Transcatheter Pacing System and Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-03-25 |
P980035-S674 |
Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-03-25 |
P860004-S369 |
Drug Delivery Infusion Pumps SynchroMed |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-03-25 |
P140032-S067 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-03-25 |
P080006-S160 |
Attain Performa Lead and Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-03-24 |
P130021-S089 |
Evolut PRO+ System |
30-Day Notice |
NPT |
— |
— |
| 2021-03-16 |
P150033-S097 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-03-12 |
P980035-S678 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Attesta D |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-03-12 |
P140010-S058 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-03-12 |
P130021-S087 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Pro Delivery Catheter Syst |
30-Day Notice |
NPT |
— |
— |
| 2021-03-12 |
P010015-S471 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-03-11 |
P100047-S175 |
HeartWare HVAD System |
30-Day Notice |
DSQ |
— |
— |
| 2021-03-11 |
P080006-S159 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-03-08 |
P980035-S672 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-03-08 |
P200028-S001 |
DiamondTemp Ablation Catheters |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-03-08 |
P010015-S468 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-03-04 |
P980050-S132 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-03-04 |
P950024-S098 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-03-04 |
P930039-S223 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2021-03-04 |
P920015-S253 |
HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-03-04 |
P920015-S252 |
HV Splitter/Adapter kit, Sprint Quattro Lead |
Real-Time Process |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2021-03-04 |
P890003-S442 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-03-04 |
P120017-S027 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2021-03-04 |
P090013-S314 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-03-04 |
P080006-S158 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-03-04 |
P060039-S106 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-03-04 |
P010015-S466 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, S |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-03-03 |
P980035-S675 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-03-03 |
P980035-S671 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-03-03 |
P150033-S093 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-03-03 |
P010015-S467 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-03-02 |
P140010-S056 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-03-02 |
P130021-S086 |
CoreValve EnVeo R Delivery Catheter System, CoreValve EnVeo R Loading System, CoreValve EnVeo Proo Delivery Catheter Sys |
30-Day Notice |
NPT |
— |
— |
| 2021-02-26 |
P130021-S085 |
Evolut PRO+ Transcatheter Aortic Valves of the Evolut PRO+ System |
Real-Time Process |
NPT |
— |
— |
| 2021-02-25 |
P120010-S139 |
MiniMed 530G System |
Special (Immediate Track) |
OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
| 2021-02-18 |
P150033-S092 |
Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-02-17 |
P980035-S673 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-02-16 |
P150033-S094 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2021-02-12 |
P980035-S670 |
CareLink SmartSync Azure Astra Application |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-02-12 |
P100047-S149 |
HeartWare HVAD System |
Normal 180 Day Track No User Fee |
DSQ |
— |
— |
| 2021-02-12 |
P010015-S464 |
CareLink SmartSync Percepta Serena Solara Application |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-02-10 |
P960009-S395 |
Activa® Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-02-09 |
P980035-S663 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-02-09 |
P890003-S438 |
MyCareLink Patient Monitor |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-02-09 |
P150033-S088 |
Micra AV TPS, Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2021-02-09 |
P080006-S157 |
Attain Ability Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-02-09 |
P080006-S156 |
Attain Ability Straight Left Ventricular Lead |
Normal 180 Day Track No User Fee |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2021-02-09 |
P010015-S465 |
Attain Bipolar OTW Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-02-09 |
P010015-S458 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-02-08 |
P050053-S055 |
Infuse Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2021-02-04 |
P140010-S055 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2021-01-28 |
P980035-S659 |
Astra S DR MRI, Astra S SR MRI, Astra XT DR MRI, Astra XT SR MRI, Azure S DR MRI, Azure S SR MRI, Azure XT DR MRI, Azure |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-01-28 |
P200028 |
DiamondTemp Ablation System |
Original |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2021-01-28 |
P010015-S456 |
Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, and Solara Quadripolar dual |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-01-21 |
P890003-S437 |
Adaptor Assembly Cable, ECG Cable, Patient Cable, and Analyzer Cable |
Normal 180 Day Track |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2021-01-21 |
P150033-S090 |
Micra AV TPS, Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2021-01-15 |
P960009-S394 |
Percept Deep Brain Stimulation Therapy Systems |
Special (Immediate Track) |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-01-15 |
P960009-S393 |
Percept Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-01-15 |
P860004-S361 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-01-15 |
P140032-S058 |
Implantable System for Remodulin (ISR) |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-01-15 |
P130021-S082 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2021-01-08 |
P960009-S392 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-01-08 |
P860004-S367 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-01-08 |
P140032-S065 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2021-01-06 |
P130021-S084 |
Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System and Evolut R TAV of the Evolut R Syst |
30-Day Notice |
NPT |
— |
— |
| 2021-01-05 |
P990064-S083 |
Mosaic Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2021-01-05 |
P980043-S074 |
Hancock II Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2021-01-05 |
P970031-S068 |
Freestyle Bioprosthesis |
135 Review Track For 30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2021-01-05 |
P870078-S048 |
Hancock Valved Conduit |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2021-01-05 |
P050053-S052 |
Infuse Bone Graft |
135 Review Track For 30-Day Notice |
NPZ |
— |
— |
| 2020-12-23 |
P930029-S069 |
RF Conductr, RF Contactr, RF Marinr, RF Marinr Unipolar, and RF Enhancr II |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-12-22 |
P980035-S667 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
Normal 180 Day Track No User Fee |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-22 |
P930039-S220 |
CapSureFix Novus Lead |
Normal 180 Day Track No User Fee |
NVN |
— |
— |
| 2020-12-22 |
P090013-S313 |
CapSureFix MRI Lead |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-21 |
P100047-S169 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-12-18 |
P980035-S665 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-18 |
P960009-S390 |
Activa Deep Brain Stimulation Therapy System and Percept PC BrainSense Implantable Neurostimulator |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-12-18 |
P860004-S366 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-12-18 |
P140032-S064 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-12-17 |
P010015-S460 |
Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, Solara Quadripolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-16 |
P990064-S084 |
Mosaic Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2020-12-16 |
P980043-S075 |
Hancock II Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2020-12-16 |
P980035-S664 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-16 |
P970031-S069 |
Freestyle Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-12-16 |
P890003-S439 |
CareLink SmartSync Device Manager Programmer |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-16 |
P870078-S049 |
Hancock Valved Conduit |
30-Day Notice |
DYE |
— |
— |
| 2020-12-16 |
P150033-S089 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-12-16 |
P010015-S459 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-15 |
P980050-S130 |
Transvene CS/SVS Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-15 |
P980035-S666 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG. Astra XT DR/SR MRI IPG, Attesta D |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-15 |
P950024-S096 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-12-15 |
P930039-S218 |
CapSureFix Lead, CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-12-15 |
P930029-S068 |
Catheter RF Contactr, Catheter RF Enhancr II, RF Conductr MC, RF Marinr, RF Marinr 5F SC/ 5F SCXL, 5F SCXS and 5F SCXXL, |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-12-15 |
P920015-S249 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adaptor kit, IS-1 COnnector Port Pin Plug Kit, Lead Ad |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-12-15 |
P890003-S440 |
CapSure VDD-2 Lead, SErvice Kit-Pacemaker Repair Kit, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-15 |
P150033-S091 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-12-15 |
P120017-S025 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2020-12-15 |
P090013-S311 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-15 |
P080006-S153 |
Attain Ability Lead, Attain Performa Lead and Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-12-15 |
P060039-S104 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-12-15 |
P010015-S461 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar/Quadripolar CRT-P, Solara Bipolar/Quadripo |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-11 |
P980035-S669 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-11 |
P930039-S222 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-12-10 |
P980035-S668 |
Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR M |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-10 |
P930039-S221 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-12-10 |
P920015-S251 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-12-10 |
P060039-S103 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-12-08 |
P980050-S131 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-08 |
P950024-S097 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-12-08 |
P930039-S219 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead, and Vitatron Pirouet Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-12-08 |
P920015-S250 |
DF-1 Connector Port Pin Plug, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-12-08 |
P890003-S441 |
CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-12-08 |
P130021-S083 |
Evolut R, Pro and Pro+ Systems |
Special (Immediate Track) |
NPT |
— |
— |
| 2020-12-08 |
P120017-S026 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2020-12-08 |
P090013-S312 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-08 |
P080006-S155 |
Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-12-08 |
P080006-S154 |
Attain Ability Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-12-08 |
P060039-S105 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-12-08 |
P010015-S462 |
Attain Bipolar OTW Lead and Attain OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-06 |
P170006-S019 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-12-04 |
P140010-S050 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
135 Review Track For 30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-12-03 |
P920015-S248 |
HV Splitter/Adaptor kit, Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-12-01 |
P120010-S138 |
MiniMed 530G System |
30-Day Notice |
OZO |
Automated Insulin Dosing , Threshold Suspend |
Unknown |
| 2020-11-30 |
P860004-S365 |
SynchroMed Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-30 |
P140032-S063 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-25 |
P980035-S662 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-25 |
P010015-S457 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-11-24 |
P980035-S661 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-24 |
P140010-S054 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-11-23 |
P100047-S159 |
HeartWare Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2020-11-19 |
P960009-S388 |
Activa Deep Brain Stimulation Therapy System, Percept PC BrainSense Implantable Neurostimulator |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-11-19 |
P860004-S364 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-19 |
P140032-S062 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-18 |
P980050-S129 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-11-18 |
P980035-S658 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-18 |
P960009-S389 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-11-18 |
P950024-S095 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-11-18 |
P930039-S217 |
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-11-18 |
P920015-S247 |
HV Splitter/Adaptor Kit, IS-1 Connector Port Pin Plug Kit, Sprint Quattro Lead, Subcutaneous Lead, and Transvene CS/SVC |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-11-18 |
P890003-S436 |
CapSure VDD-2 Lead, CareLink SmartSync Device Manager Programmer and Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-18 |
P860004-S363 |
SynchroMed Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-18 |
P150033-S087 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-11-18 |
P140032-S061 |
Implantable System for Remodulin |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-18 |
P120017-S024 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2020-11-18 |
P100047-S163 |
HeartWare Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-11-18 |
P090013-S310 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-11-18 |
P080006-S152 |
Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-11-18 |
P060039-S102 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-11-18 |
P010015-S455 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-11-18 |
P010015-S454 |
Percepta Quadripolar CRT-P, Serena Quadripolar CRT-P, and Solara Quadripolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-11-16 |
P980035-S655 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-12 |
P980035-S660 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-12 |
P960009-S387 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-11-12 |
P960009-S386 |
Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-11-10 |
P860004-S352 |
SynchroMed Infusion System |
135 Review Track For 30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-10 |
P140032-S049 |
Implantable System for Remodulin (ISR) |
135 Review Track For 30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-11-03 |
P990064-S082 |
Mosaic Bioprosthesis and Mosaic Ultra Bioprosthesis |
135 Review Track For 30-Day Notice |
DYE |
— |
— |
| 2020-11-03 |
P980035-S653 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Attesta DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-03 |
P960009-S382 |
Activa Deep Brain Stimulation Therapy System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-11-02 |
P980035-S638 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-02 |
P890003-S434 |
MyCareLink Patient Monitor |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-11-02 |
P150033-S085 |
Micra AV TPS and Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2020-11-02 |
P010015-S447 |
Consulta CRT-P, Syncra CRT-P, and Viva CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-30 |
P130021-S081 |
EnVeo PRO Delivery Catheter System, EnVeo R Delivery Catheter System, Evolut PRO+ Delivery Catheter System, EnVeo PRO Lo |
30-Day Notice |
NPT |
— |
— |
| 2020-10-28 |
P980035-S657 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-28 |
P980035-S651 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-28 |
P960009-S383 |
Activa Deep Brain Stimulation Therapy System and Percept PC Deep Brain Stimulation Therapy System |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-10-28 |
P010015-S453 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-26 |
P980035-S650 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-26 |
P930039-S216 |
CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-10-22 |
P980035-S649 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-22 |
P170006-S018 |
Avalus Bioprosthesis |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-10-22 |
P150033-S086 |
Micra AV TPS and Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-10-22 |
P010015-S452 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-21 |
P980035-S656 |
Adapta, Versa, Sensia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-21 |
P140032-S047 |
Implantable System for Remodulin |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-10-20 |
P980035-S654 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-15 |
P980035-S648 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-15 |
P930039-S215 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline ActFix Lead, and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-10-15 |
P920015-S246 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-10-15 |
P890003-S435 |
CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-15 |
P090013-S309 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-14 |
P140010-S052 |
IN.PACT Admiral Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-10-13 |
P980035-S646 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-13 |
P980035-S645 |
Adapta, Versa, Sensia IPG and Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-09 |
P980035-S644 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-09 |
P010015-S451 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT- |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-08 |
P980035-S652 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG, and Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-08 |
P980035-S637 |
Medtronic Attesta and Sphera MRI SureScan IPG and Pacing System |
Normal 180 Day Track No User Fee |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-07 |
P980035-S647 |
Adapta, Versa, Sensia IPG and Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-06 |
P980035-S643 |
Adapta, Versa, Sensia IPG and Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-10-06 |
P100047-S172 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-10-05 |
P140010-S051 |
IN.PACT Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter |
Normal 180 Day Track No User Fee |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-10-05 |
P130021-S080 |
CoreValve Evolut R and Evolut PRO System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2020-10-01 |
P960009-S384 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-09-30 |
P980035-S642 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-09-30 |
P100047-S171 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-09-30 |
P010015-S450 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-09-29 |
P150033-S077 |
Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2020-09-25 |
P980035-S641 |
MEDTRONIC KAPPA 700/600 SERIES PULSE GENERATORS AND MODEL 9953 SOFTWARE |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-09-25 |
P930029-S067 |
RF Conductr, RF Contactr, RF Marinr, and RF Enhancr II |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-09-23 |
P980035-S640 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-09-23 |
P010015-S449 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-09-22 |
P860004-S360 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-09-22 |
P140032-S057 |
Implantable System for Remodulin |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-09-22 |
P080006-S151 |
Attain Performa Lead and Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-09-18 |
P980035-S639 |
Adapta, Versa, Sensia IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-09-15 |
P010015-S448 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-09-11 |
P960009-S381 |
Percept Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-09-09 |
P960009-S380 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-09-09 |
P860004-S362 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-09-09 |
P140032-S060 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-09-06 |
P960009-S379 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-09-06 |
P140032-S059 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-09-04 |
P100047-S170 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-09-03 |
P100047-S166 |
HeartWare HVAD System |
Real-Time Process |
DSQ |
— |
— |
| 2020-08-27 |
P150033-S084 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-08-27 |
P050053-S054 |
Infuse Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2020-08-25 |
P890003-S431 |
MyCareLink Smart Monitor System |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-08-24 |
P980035-S636 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-08-24 |
P150033-S083 |
Micra AV TPS and Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-08-24 |
P010015-S446 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-08-21 |
P960009-S377 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-08-21 |
P860004-S338 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-08-20 |
P170006-S017 |
Avalus Bioprosthesis |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-08-17 |
P130021-S076 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System, and Medtronic Evolut PRO+ System |
Normal 180 Day Track |
NPT |
— |
— |
| 2020-08-12 |
P960009-S378 |
Activa Deep Brain Stimulation Therapy Systems |
Special (Immediate Track) |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-08-12 |
P010015-S439 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-08-11 |
P150033-S081 |
Micra TPS and Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-08-06 |
P980050-S128 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-08-06 |
P950024-S094 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-08-06 |
P930039-S214 |
CapSureFix Lead, CapSureFix Novus Lead, and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-08-06 |
P920015-S245 |
Y Adaptor/Extender Kit, HV Splitter/Adaptor kit, IS-1 Connector Port Pin Plug Kit, Lead Adaptor, Sprint Quattro Lead, Su |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-08-06 |
P890003-S433 |
CapSure VDD-2 Lead, Service Kit-Pacemaker Repair Kit, and Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-08-06 |
P120017-S023 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2020-08-06 |
P100047-S151 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-08-06 |
P090013-S308 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-08-06 |
P080006-S150 |
Attain Ability Lead, Attain Performa Lead, and Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-08-06 |
P060039-S101 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-08-06 |
P010015-S444 |
Attain Bipolar OTW Lead and Attain OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-08-05 |
P980035-S633 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-08-04 |
P980035-S634 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-08-04 |
P150033-S079 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-08-04 |
P010015-S443 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-08-03 |
P980035-S635 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-08-03 |
P150033-S082 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-08-03 |
P150033-S080 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-08-03 |
P010015-S445 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-07-30 |
P150033-S078 |
Micra AV TPS |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2020-07-29 |
P980035-S632 |
Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-07-29 |
P010015-S442 |
Consulta, Percepta Bipolar, Percepta Quadripolar, Serena Bipolar, Serena Quadripolar, Solara Bipolar, Solara Quadripolar |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-07-24 |
P980035-S628 |
Adapta Versa Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, En |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-07-24 |
P890003-S430 |
MyCareLink Network, Micra AV family of pacemakers |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-07-24 |
P150033-S075 |
Micra AV TPS, Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2020-07-24 |
P010015-S438 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-07-23 |
P930029-S066 |
RF Conductr, RF Contactr, RF Marinr, RF Enhancr II |
30-Day Notice |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2020-07-22 |
P980050-S127 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-07-22 |
P980035-S631 |
Adapta, Versa, Sensia IPG, Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-07-22 |
P950024-S093 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-07-22 |
P930039-S212 |
CapSureFix Lead, CapSureFix Novus Lead, Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-07-22 |
P920015-S244 |
Y Adaptor/Extender Kit, DF-1 Connector Port Pin Plug, HV Splitter/Adapter kit, IS-1 Connector Port Pin Plug Kit, Lead Ad |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-07-22 |
P890003-S432 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-07-22 |
P150033-S076 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-07-22 |
P120017-S022 |
Myocardial Pacing Lead |
30-Day Notice |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2020-07-22 |
P090013-S306 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-07-22 |
P080006-S149 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-07-22 |
P060039-S100 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-07-22 |
P010015-S441 |
Attain Bipolar OTW Lead, Attain OTW LV Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-07-20 |
P100047-S168 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-07-15 |
P100047-S167 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-07-15 |
P080006-S147 |
Attain Ability Lead, Attain Performa Lead, Attain Stability Quad MRI Lead |
Real-Time Process |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-07-13 |
P130021-S079 |
Evolut PRO+ TAV of the Evolut PRO+ System, Evolut PRO TAV of the Evolut PRO System, Evolut R TAV of the Evolut R System |
30-Day Notice |
NPT |
— |
— |
| 2020-07-10 |
P930039-S213 |
CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-07-10 |
P090013-S307 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-07-10 |
P050053-S050 |
Infuse Bone Graft |
30-Day Notice |
NPZ |
— |
— |
| 2020-07-09 |
P100047-S132 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-07-08 |
P980035-S629 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-07-08 |
P010015-S440 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-26 |
P130021-S078 |
EnVeo R, EnVeo PRO and Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R/PRO/PRO+ Systems |
30-Day Notice |
NPT |
— |
— |
| 2020-06-25 |
P960009-S365 |
Activia Deep Brain Stimulation Therapy System |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-06-24 |
P960009-S361 |
(MBX, MHY, NHL, PJS) -Master Percept and Activa Deep Brain Stimulation Therapy Systems |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-06-23 |
P980035-S630 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Attesta SR MRI IPG, Sphera DR MRI IPG, Sphera SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-06-23 |
P080006-S148 |
Attain Stability Quard MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-06-22 |
P100047-S164 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-06-18 |
P010015-S437 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-17 |
P150033-S070 |
Micra Transcatheter Pacing System |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2020-06-11 |
P130021-S077 |
Evolut R, Evolut PRO and Evolut PRO+ Transcatheter Aortic Valves (TAV)s |
30-Day Notice |
NPT |
— |
— |
| 2020-06-09 |
P960009-S375 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-06-09 |
P860004-S359 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-06-09 |
P140032-S056 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-06-08 |
P980035-S627 |
Adapta, Versa,Sensia IPG,Advisa DR IPG,Advisa DR MRI IPG,Advisa SR MRI IPG,Astra S DR MRI IPG,Astra S SR MRI IPG,Astra X |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-06-08 |
P150033-S074 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-06-08 |
P010015-S436 |
Consulta CRT-P,Percepta Bipolar CRT-P,Percepta Quadripolar CRT-P,Serena Bipolar CRT-P,Serena Quadripolar CRT-P,Solara Bi |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-03 |
P100047-S162 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-06-02 |
P980050-S126 |
Transvene CS/SVC Lead |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-02 |
P950024-S092 |
CapSure Epicardial Pacing Lead |
Real-Time Process |
NVN |
— |
— |
| 2020-06-02 |
P930039-S211 |
CapSureFix Lead |
Real-Time Process |
NVN |
— |
— |
| 2020-06-02 |
P920015-S243 |
Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Subcutaneous Lead, Transven |
Real-Time Process |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-06-02 |
P890003-S429 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-06-02 |
P150033-S073 |
Micra AV Transcatheter Pacing System |
30-Day Notice |
PNJ |
— |
— |
| 2020-06-02 |
P120017-S021 |
Myocardial Pacing Lead |
Real-Time Process |
DTB |
Permanent Pacemaker Electrode |
Cardiovascular |
| 2020-05-28 |
P130021-S072 |
Evolut R, Evolut PRO and Evolut PRO+ Systems |
Real-Time Process |
NPT |
— |
— |
| 2020-05-26 |
P980035-S626 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-21 |
P150033-S072 |
Micra AV TPS, Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-05-20 |
P860004-S358 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-05-20 |
P140032-S055 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-05-17 |
P980035-S619 |
CareLink SmartSync Azure Astra Application, Azure S DR MRI IPG Azure S sR MRI IRG and Azure XT DR/SR MRI IPG |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-17 |
P890003-S428 |
CareLink SmartSync Platform and Common Application |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-17 |
P010015-S430 |
CaareLink SmartSync Percepta Serena Solara Application, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipol |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-05-15 |
P980035-S616 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-15 |
P890003-S427 |
MyCareLink Patient Monitor |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-15 |
P860004-S345 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
135 Review Track For 30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-05-15 |
P150033-S067 |
Micra TPS, Micra AV |
Real-Time Process |
PNJ |
— |
— |
| 2020-05-15 |
P010015-S428 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-14 |
P860004-S357 |
SynchroMed Infusion System |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-05-14 |
P140032-S054 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-05-08 |
P980035-S618 |
Astra S DR MRI IPG, Astra S SR MRI IPG, Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-08 |
P960009-S374 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-05-08 |
P860004-S356 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-05-08 |
P140032-S053 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-05-08 |
P010015-S429 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-05-07 |
P960009-S373 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-05-07 |
P100047-S142 |
HeartWare HVAD System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-05-06 |
P980043-S073 |
Hancock II Bioprothesis |
30-Day Notice |
DYE |
— |
— |
| 2020-05-06 |
P100047-S161 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-05-05 |
P130021-S075 |
CoreValve Evolut R System, CoreValve Evolut PRO and Wvolut PRO+ Transcatheter Aortic Valves (TAV) |
30-Day Notice |
NPT |
— |
— |
| 2020-05-05 |
P100047-S154 |
HeartWare Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2020-05-04 |
P980035-S625 |
Adapta IPG, Versa IPG, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR M |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-05-04 |
P010015-S435 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-05-01 |
P130021-S074 |
EnVeo R, EnVeo PRO, Evolut PRO+ Delivery Catheter Systems and Loading Systems of the Evolut R, PRO and PRO+ Systems |
30-Day Notice |
NPT |
— |
— |
| 2020-04-24 |
P100047-S144 |
HeartWare HVAD System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2020-04-23 |
P930039-S202 |
MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 |
Normal 180 Day Track |
NVN |
— |
— |
| 2020-04-23 |
P920015-S234 |
MEDTRONIC(R) TRANSVENE LEAD SYSTEM |
Normal 180 Day Track |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-04-23 |
P890003-S416 |
SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071 |
Normal 180 Day Track |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-04-23 |
P090013-S301 |
REVO MRI SURESCAN IPG AND PACING SYSTEM |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-23 |
P080006-S137 |
MEDTRONIC ATTAIN ABILITY MODEL 4196 LEAD |
Normal 180 Day Track |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-04-22 |
P980035-S624 |
Adapta, Versa, Sensia IPG, Advisa DR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, and Azure XT |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-04-22 |
P960009-S372 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-04-22 |
P860004-S355 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-04-22 |
P140032-S052 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-04-22 |
P010015-S434 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-16 |
P150033-S071 |
Micra AV Transcatheter Pacemaker System |
30-Day Notice |
PNJ |
— |
— |
| 2020-04-15 |
P980035-S622 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-04-15 |
P010015-S432 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolara CRT-P, Sol |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-14 |
P980035-S623 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG, Astra S DR/SR MRI IPG, Astra XT DR/SR MRI IPG, Azure S D |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-04-14 |
P010015-S433 |
Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Solara Bipolar CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-08 |
P100047-S157 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-04-07 |
P960009-S371 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-04-07 |
P860004-S354 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-04-07 |
P140032-S051 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-04-06 |
P980035-S621 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-04-06 |
P150033-S068 |
Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-04-06 |
P010015-S431 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-04-02 |
P860004-S353 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-04-02 |
P140032-S050 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-04-01 |
P150033-S069 |
Micra Transcatheter Pacing System and Micra AV TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-04-01 |
P100047-S155 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-03-30 |
P100047-S156 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-03-27 |
P960009-S370 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-03-23 |
P990034-S039 |
IsoMed Infusion System |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-03-23 |
P860004-S334 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
Normal 180 Day Track |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-03-20 |
P960009-S369 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-03-20 |
P130021-S073 |
Medtronic CoreValve Evolut R System, Medtronic CoreValve Evolut PRO System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2020-03-20 |
P100047-S158 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-03-19 |
P080006-S145 |
Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-03-06 |
P980035-S615 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-03-06 |
P950024-S091 |
CapSure Epicardial Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-03-06 |
P930039-S210 |
CapSureFix Lead, CapSureFix Novus Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-03-06 |
P920015-S242 |
Y Adapter/Extender Kit, IS-1 Connector Port Pin Plug Kit, Lead Adapter, Sprint Quattro Lead, Transvene CS/SVC Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-03-06 |
P890003-S426 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+VDD Lead |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-03-06 |
P150033-S066 |
Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-03-06 |
P090013-S305 |
CapSureFix MRI Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-06 |
P080006-S146 |
Attain Ability Lead, Attain Stability Quad MRI Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-03-06 |
P060039-S099 |
Attain StarFix Lead |
30-Day Notice |
OJX |
Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode |
Unknown |
| 2020-03-06 |
P010015-S427 |
Attain Bipolar OTW Lead, Attain OTW LV Lead, Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-05 |
P980035-S620 |
Adapta, Versa, Sensia IPG, Attesta DR MRI IPG, Sphera DR MRI IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-03-03 |
P980035-S617 |
Adapta, Versa, Sensia IPG, Advisa SR MRI IPG, Attesta DR MRI IPG/Attesta SR MRI IPG, Relia IPG, Sphera DR MRI IPG/Sphera |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-03-03 |
P100047-S153 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-03-02 |
P980035-S614 |
Adapta, Versa, Sensia, IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-03-02 |
P890003-S425 |
Synergyst II Pulse Generator |
Real-Time Process |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-03-02 |
P150033-S065 |
Micra TPS |
Real-Time Process |
PNJ |
— |
— |
| 2020-03-02 |
P010015-S426 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-02-28 |
P130021-S071 |
Medtronic CoreValve Evolut R, Medtronic CoreValve Evolut PRO, and Medtronic Evolut PRO+ transcatheter aortic valves (TAV |
30-Day Notice |
NPT |
— |
— |
| 2020-02-20 |
P140010-S049 |
In.Pact Admiral Paclitaxel-Coated Percutaneous Transluminal Angioplasty Balloon Catheter |
30-Day Notice |
ONU |
Drug-Eluting Peripheral Transluminal Angioplasty Catheter |
Unknown |
| 2020-02-18 |
P100047-S152 |
HeartWare Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-02-05 |
P960009-S368 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-02-05 |
P050053-S045 |
Infuse Bone Graft |
135 Review Track For 30-Day Notice |
NPZ |
— |
— |
| 2020-02-04 |
P930039-S209 |
CapSureFix Novus Lead and Vitatron Crystalline Active Fixation Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-02-03 |
P860004-S346 |
SynchroMed Infusion System and Ascenda Intrathecal Catheters |
Real-Time Process |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-02-02 |
P990064-S081 |
Mosaic Bioprosthesis |
30-Day Notice |
DYE |
— |
— |
| 2020-01-29 |
P960009-S363 |
Activa Deep Brain Stimulation Therapy System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-01-28 |
P920015-S241 |
Sprint Quattro Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-01-27 |
P100047-S150 |
HeartWare HVAD System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2020-01-22 |
P860004-S351 |
SynchroMed Infusion System, Ascenda Intrathecal Catheter |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-01-22 |
P140032-S048 |
Implantable System for Remodulin |
Special (Immediate Track) |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-01-15 |
P150033-S061 |
Micra Transcatheter Pacing System, Micra AV Application Software |
Normal 180 Day Track |
PNJ |
— |
— |
| 2020-01-10 |
P980050-S125 |
Transvene CS/SVC Lead |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-01-10 |
P920015-S240 |
Sprint Quattro, Subcutaneous Lead, Transvene CS/SVC Lead |
30-Day Notice |
NVY |
Permanent Defibrillator Electrodes |
Unknown |
| 2020-01-09 |
P980035-S612 |
Adapta Versa Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Advisa SR MRI IPG, Astra S DR MRI IPG, Astra S SR MRI IPG, As |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-01-09 |
P960009-S367 |
Activia Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-01-09 |
P960009-S366 |
Activa Deep Brain Stimulation Therapy System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-01-09 |
P860004-S350 |
SynchroMed Infusion System, Ascenda Intrathecal Catheters |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-01-09 |
P860004-S349 |
Drug Delivery Infusion Pumps SynchroMed |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-01-09 |
P150033-S064 |
Micra TPS |
30-Day Notice |
PNJ |
— |
— |
| 2020-01-09 |
P140032-S046 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-01-09 |
P140032-S045 |
Implantable System for Remodulin |
30-Day Notice |
LKK |
Pump, Infusion, Implanted, Programmable |
Unknown |
| 2020-01-09 |
P010015-S425 |
Consulta CRT-P, Percepta Bipolar CRT-P, Percepta Quadripolar CRT-P, Serena Bipolar CRT-P, Serena Quadripolar CRT-P, Sola |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-01-07 |
P980035-S611 |
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR/SR MRI IPG and Relia IPG |
30-Day Notice |
NVZ |
Pulse Generator, Permanent, Implantable |
Unknown |
| 2020-01-07 |
P010015-S424 |
Consulta CRT-P, Syncra CRT-P and Viva CRT-P |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |