| 2026-08-12 |
P910023-S487 |
Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q, CDDRA800Q, CDDRA600Q, CDVRA600T, |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-08-12 |
P160054-S131 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2026-08-12 |
P060040-S126 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-08-12 |
P030054-S446 |
Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T, CDHFA600Q, |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-08-11 |
P250022-S008 |
Volt PFA Catheter, Sensor Enabled |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-08-11 |
P040021-S062 |
Epic, Epic Supra, Epic Plus, Epic Plus Supra and Epic Max, Epic Elite, and Epic Supra G3 Stented Tissue Valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-08-07 |
P240042-S003 |
Tendyne Transcatheter Mitral Valve System |
30-Day Notice |
NPU |
Prosthesis, Mitral Valve, Percutaneously Delivered |
Unknown |
| 2026-08-07 |
P220013-S033 |
TactiSys Quartz Equipment; Ampere Generator |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-08-07 |
P140009-S133 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-08-07 |
P110016-S095 |
Ampere Generator |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2026-08-07 |
P010032-S254 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Real-Time Process |
LGW |
— |
— |
| 2026-07-30 |
P160054-S130 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2026-07-26 |
P150004-S099 |
Dorsal Root Ganglion (DRG) IPG |
30-Day Notice |
PMP |
— |
— |
| 2026-07-26 |
P140009-S138 |
Deep Brain Stimulation (DBS) IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-07-26 |
P010032-S259 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2026-07-23 |
P250022-S005 |
Current PFA Generator TactiFlex Duo |
Real-Time Process |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-07-23 |
P220013-S030 |
TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-07-21 |
P970013-S099 |
Microny family of Pacemakers |
Normal 180 Day Track |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2026-07-21 |
P910023-S482 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-21 |
P880086-S345 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2026-07-21 |
P150035-S035 |
Aveir Leadless System |
Normal 180 Day Track |
PNJ |
— |
— |
| 2026-07-21 |
P140033-S101 |
Assurity MRI / Endurity MRI Pacemakers |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2026-07-21 |
P030054-S440 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-07-21 |
P030035-S211 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2026-07-17 |
P140009-S134 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-07-17 |
P010032-S255 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2026-07-16 |
P160054-S129 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2026-07-10 |
P250022-S006 |
Volt PFA System |
Normal 180 Day Track No User Fee |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-07-09 |
P910023-S486 |
Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-07-09 |
P230036-S017 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
Normal 180 Day Track |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2026-07-09 |
P190023-S034 |
Navitor Transcatheter Aortic Valve Implantation System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2026-07-09 |
P160054-S128 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-07-09 |
P060040-S125 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-07-09 |
P030054-S445 |
Avant (CDHFA700Q, CDHFA700T, CDHFA700D); Neutrino NxT (CDHFA800Q, CDHFA800T, CDHFA800B, CDHFA800D, CDHFA600Q, CDHFA600T, |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-07-02 |
P140009-S132 |
Liberta RC Deep Brain Stimulation (DBS) IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-07-02 |
P010032-S253 |
Etema Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2026-07-01 |
P160054-S127 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-06-30 |
P150004-S095 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
Real-Time Process |
PMP |
— |
— |
| 2026-06-26 |
P960030-S085 |
IsoFlex Leads |
30-Day Notice |
NVN |
— |
— |
| 2026-06-26 |
P960013-S134 |
Tendril STS Leads; Ultipace Leads; Optisense Leads |
30-Day Notice |
NVN |
— |
— |
| 2026-06-26 |
P950022-S154 |
Durata Leads; Optisure Leads; UltiSync Leads |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-06-25 |
P230007-S023 |
TriClip Systems |
30-Day Notice |
NPS |
— |
— |
| 2026-06-25 |
P100009-S086 |
MitraClip Systems |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2026-06-22 |
P250022-S007 |
VOLT PFA CATHETER, SENSOR ENABLED |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-06-22 |
P040021-S061 |
Epic Elite Mitral; Epic Elite Aortic; Epic Supra G3 valves |
Normal 180 Day Track |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2026-06-17 |
P150035-S040 |
AVEIR Patient Transmitter LSRM01 |
30-Day Notice |
PNJ |
— |
— |
| 2026-06-11 |
P960030-S084 |
UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2026-06-11 |
P960013-S133 |
UltiPace Low Voltage LPA1231, Tendril Low Voltage 2088TC, OptiSense Low Voltage 1999, Isoflex Low Voltage 1944/1948, Ten |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2026-06-11 |
P810002-S126 |
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2026-06-11 |
P150035-S039 |
The AVEIR Leadless Pacemaker (LP) |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2026-06-10 |
P160054-S125 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2026-06-10 |
P060040-S124 |
HeartMate II Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2026-06-05 |
P220013-S031 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-06-05 |
P110016-S094 |
FlexAbility Ablation Catheter; FlexAbilityTM Ablation Catheter, Sensor EnabledTM |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2026-06-03 |
P190023-S029 |
Navitor TAVI System with Vision Technology |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2026-06-01 |
P100045-S090 |
CardioMEMS HF System |
Normal 180 Day Track No User Fee |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2026-05-29 |
P220013-S032 |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-05-29 |
P160054-S121 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2026-05-29 |
P150035-S038 |
Aveir VR (LSCD111); DR Delivery Catheter (LSCD201) |
Real-Time Process |
PNJ |
— |
— |
| 2026-05-29 |
P060040-S123 |
HeartMate II Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2026-05-28 |
P230007-S022 |
TriClip Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2026-05-28 |
P220013-S022 |
TactiFlex Sensor Enabled Ablation Catheter |
Normal 180 Day Track |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-05-28 |
P200049-S018 |
AmplatzerTM Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-05-28 |
P120021-S028 |
AmplatzerTM PFO Occluder; AmplatzerTM Talisman PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2026-05-28 |
P100009-S085 |
MitraClip Delivery Systems |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2026-05-28 |
P040040-S051 |
AmplatzerTM Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2026-05-28 |
P020024-S073 |
AmplatzerTM Duct Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2026-05-28 |
P000039-S084 |
AmplatzerTM Septal Occluder; AmplatzerTM Multifenestrated Septal Occluder - Cribriform |
30-Day Notice |
MLV |
— |
— |
| 2026-05-27 |
P160054-S122 |
HeartMate 3 Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2026-05-26 |
P190023-S032 |
Navitor Transcatheter Aortic Valve Implantation System |
30-Day Notice |
NPT |
— |
— |
| 2026-05-26 |
P010032-S252 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2026-05-22 |
P230036-S018 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2026-05-15 |
P220013-S029 |
TactiFlex Ablation Catheter, Sensor Enabled (A-TFSE-D; A-TFSE-F; A-TFSE-J; A-TFSE-DD; A-TFSE-DF; A-TFSE-FF; A-TFSE-FJ; |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-05-14 |
P230007-S021 |
TriClip Systems |
30-Day Notice |
NPS |
— |
— |
| 2026-05-14 |
P100009-S084 |
MitraClip Systems |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2026-05-13 |
P100045-S089 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2026-04-30 |
P150004-S094 |
Proclaim Dorsal Root Ganglion (DRG) IPG |
30-Day Notice |
PMP |
— |
— |
| 2026-04-30 |
P140009-S131 |
Infinity Deep Brain Stimulation (DBS) IPG; Liberta RC DBS IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-04-30 |
P010032-S250 |
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna SCS IPG |
30-Day Notice |
LGW |
— |
— |
| 2026-04-25 |
P140009-S130 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
Special (Immediate Track) |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-04-25 |
P010032-S249 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Special (Immediate Track) |
LGW |
— |
— |
| 2026-04-24 |
P950022-S152 |
Durata Leads (7120, 7121, 7122, 7120Q, 7121Q, 7122Q, 7170, 7170Q, 7172Q, 7171Q) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-04-24 |
P030054-S444 |
Optisure Leads (LDA210, LDA210Q, LDA220Q, LDP210Q, LDP220Q, LDA230Q, LDP230Q); Quartet Leads (1456Q, 1457Q, 1458Q, 1456Q |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-04-16 |
P250022-S003 |
Volt PFA System |
Real-Time Process |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-04-15 |
P190023-S030 |
Navitor Transcatheter Aortic Valve Implantation System |
Normal 180 Day Track |
NPT |
— |
— |
| 2026-04-13 |
P250022-S004 |
Volt PFA Catheter, Sensor Enabled |
30-Day Notice |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-04-09 |
P110016-S093 |
FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2026-04-03 |
P150035-S036 |
AVEIR Leadless Pacemaker, ventricular (LSP112V, LSP202V); Aveir Delivery Catheter (LSCD111, LSCD201) |
Real-Time Process |
PNJ |
— |
— |
| 2026-04-02 |
P160054-S124 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2026-03-27 |
P910023-S485 |
Avant (CDVRA700Q, CDDRA700Q, CDVRA700T, CDDRA700T); Neutrino NxT (CDVRA800Q, CDVRA600Q CDDRA800Q, CDDRA600Q CDVRA600T, C |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-03-27 |
P030054-S443 |
Avant (CDHFA700Q, CDHFA700B, CDHFA700D, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800B, CDHFA800D, CDHFA800T); Gallant ( |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-03-25 |
P160054-S123 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-03-25 |
P100045-S088 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2026-03-23 |
P250022-S001 |
Volt PFA Catheter Sensor Enabled |
Normal 180 Day Track |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2026-03-19 |
P200049-S017 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-03-17 |
P190023-S031 |
Navitor Transcatheter Aortic Valve Implantation System |
30-Day Notice |
NPT |
— |
— |
| 2026-03-13 |
P150004-S093 |
Proclaim Doral Root Ganglion (DRG) IPG |
30-Day Notice |
PMP |
— |
— |
| 2026-03-13 |
P140009-S129 |
Infinity Deep Brain Stimulation (DBS) IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-03-13 |
P010032-S248 |
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2026-03-06 |
P230007-S020 |
TriClip G4 System |
30-Day Notice |
NPS |
— |
— |
| 2026-03-06 |
P100009-S083 |
MitraClip NTR/XTR Clip Delivery System; MitraClip G4 System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2026-03-04 |
P160054-S120 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-03-04 |
P160054-S119 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-03-02 |
P160054-S114 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2026-02-27 |
P100045-S086 |
Next Gen Patient System CM1200 CardioMEMS HERO Device |
Normal 180 Day Track |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2026-02-25 |
P230007-S019 |
TriClip G5 Delivery System (TCDS0801-NT, TCDS0801-NTW, TCDS0801-XT, TCDS0801-XTW) |
Real-Time Process |
NPS |
— |
— |
| 2026-02-25 |
P100009-S082 |
MitraClip G5 Delivery System (CDS0801-NT, CDS0801-NTW, CDS0801-XT, CDS0801-XTW) |
Real-Time Process |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2026-02-24 |
P200049-S016 |
Amplatzer Amulet Left Atrial Appendage Occluder (Amulet) |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-02-23 |
P150035-S034 |
Aveir DR Delivery Catheter (LSCD201) |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2026-02-19 |
P960030-S080 |
IsoFlex |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2026-02-19 |
P960013-S129 |
Tendril STS; OptiSense; UltiPace |
135 Review Track For 30-Day Notice |
NVN |
— |
— |
| 2026-02-19 |
P950022-S148 |
Durata, Optisure |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-19 |
P150035-S026 |
Aveir VR Leadless Pacemaker, Aveir Leadless Pacemaker (Right Ventricular) |
135 Review Track For 30-Day Notice |
PNJ |
— |
— |
| 2026-02-19 |
P030054-S435 |
Quartet; QuickFlex Micro |
135 Review Track For 30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-02-18 |
P160054-S115 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2026-02-18 |
P060040-S121 |
HeartMate II Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2026-02-13 |
P910023-S483 |
Avant (CDVRA700Q, CDVRA700T); Neutrino NxT (CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T); Gallant (CDVRA500Q, CDVRA500T); |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2026-02-13 |
P030054-S441 |
Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2026-02-12 |
P200049-S015 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2026-02-12 |
P020024-S072 |
Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2026-02-11 |
P160054-S118 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-02-11 |
P140009-S126 |
8CH Infinity DBS Lead Kit, 30cm, 0.5, B; 8CH Infinity DBS Lead Kit, 30cm, 1.5, B; 8CH Infinity DBS Lead Kit, 40cm, 0 |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-02-11 |
P010032-S245 |
8-channel adapter, M, 10cm; 8-channel adapter, M, 60cm; 8-channel adapter, B, 10cm; 8-channel adapter, B, 60cm; Legacy M |
Real-Time Process |
LGW |
— |
— |
| 2026-02-10 |
P140009-S128 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2026-02-10 |
P010032-S247 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2026-02-04 |
P160054-S117 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2026-02-03 |
P220013-S027 |
TactiFlex Ablation Catheter SE (A-TFSE-D, A-TFSE-F, A-TFSE-J, A-TFSE-DD, A-TFSE-DF, A-TFSE-FF, A-TFSE-FJ, A-TFSE-JJ, A-T |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-01-15 |
P220013-S026 |
TactiFlex Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-01-15 |
P110016-S092 |
FlexAbility and FlexAbility Sensor Enabled |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2026-01-13 |
P150004-S085 |
Proclaim Dorsal Root Ganglion (DRG) Neurostimulator System |
Normal 180 Day Track |
PMP |
— |
— |
| 2026-01-13 |
P010032-S237 |
Eterna SCS and Proclaim SCS Systems |
Normal 180 Day Track |
LGW |
— |
— |
| 2026-01-09 |
P100045-S082 |
CardioMEMS HF System |
135 Review Track For 30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2026-01-08 |
P220013-S025 |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2026-01-08 |
P110016-S091 |
FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-12-23 |
P200049-S014 |
Amplatzer Amulet Left Atrial Appendage Occluder |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-12-23 |
P150004-S092 |
Proclaim Dorsal Root Ganglion (DRG) System |
30-Day Notice |
PMP |
— |
— |
| 2025-12-23 |
P140009-S127 |
Infinity Deep Brain Stimulation (DBS) System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-12-23 |
P010032-S246 |
Proclaim Spinal Cord Stimulation (SCS) System |
30-Day Notice |
LGW |
— |
— |
| 2025-12-19 |
P250022 |
Volt PFA System |
Original |
QZI |
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation |
Unknown |
| 2025-12-17 |
P160054-S116 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-12-17 |
P060040-S122 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-12-09 |
P960013-S132 |
Tendril STS Leads; Ultipace Leads |
30-Day Notice |
NVN |
— |
— |
| 2025-12-09 |
P950022-S151 |
Durata Leads; Optisure Leads |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-11-20 |
P960030-S083 |
IsoFlex Pacing Leads |
Normal 180 Day Track |
NVN |
— |
— |
| 2025-11-20 |
P960013-S131 |
OptiSense Pacing Leads |
Normal 180 Day Track |
NVN |
— |
— |
| 2025-11-20 |
P950022-S150 |
Durata Defibrillation Leads |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-11-20 |
P140033-S100 |
Tendril MRI Pacing Leads / Assurity MRI, Endurity MRI, Zenex MRI, Zenus MRI Pacemakers |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-11-20 |
P030054-S439 |
Quartet and QuickFlex µ Left Heart Leads |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-11-10 |
P100045-S087 |
CardioMEMS HF System (Merlin.net PCN HF Portal (Model MN6000) and CardioMEMS Backend Web Application (Model CM4000)) |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2025-11-07 |
P150004-S090 |
Dorsal Root Ganglion (DRG) Neurostimulation System |
Normal 180 Day Track |
PMP |
— |
— |
| 2025-11-07 |
P140009-S124 |
Deep Brain Stimulation (DBS) Neurostimulation System |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-11-07 |
P010032-S243 |
Spinal Cord Stimulation (SCS) Neurostimulation System |
Normal 180 Day Track |
LGW |
— |
— |
| 2025-11-04 |
P160054-S112 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2025-10-30 |
P220013-S023 |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-10-30 |
P040021-S060 |
Epic, Epic Supra, Epic Plus, Epic Plus Supra and Epic Max Stented Tissue Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-10-28 |
P150035-S033 |
Aveir VR Leadless Pacemaker; Aveir Leadless Pacemaker (Right Atrium); Aveir Leadless Pacemaker (Right Ventricle) |
30-Day Notice |
PNJ |
— |
— |
| 2025-10-23 |
P200049-S013 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-10-23 |
P120021-S027 |
Amplatzer PFO Occluder; Amplatzer Talisman PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2025-10-23 |
P040040-S050 |
Amplatzer Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2025-10-23 |
P020024-S071 |
Amplatzer Duct Occluder; Amplatzer Duct Occluder II; Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2025-10-23 |
P000039-S083 |
Amplatzer Septal Occluder; Amplatzer Multi-Fenestrated Septal Occluder - Cribriform |
30-Day Notice |
MLV |
— |
— |
| 2025-10-22 |
P230036-S016 |
Esprit BTK RX System; Esprit BTK OTW System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2025-10-17 |
P230007-S018 |
TriClip G4 System |
30-Day Notice |
NPS |
— |
— |
| 2025-10-17 |
P160054-S094 |
HeartMate 3 Left Ventricular Assist System, HeartMate II Left Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2025-10-17 |
P100009-S081 |
MITRACLIP DELIVERY SYSTEM |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-10-17 |
P060040-S112 |
HeartMate Apical Coring Knife |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2025-10-16 |
P110016-S089 |
FlexAbility Ablation Catheter, Sensor Enabled |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-10-15 |
P810002-S125 |
Masters Series Mechanical Heart Valve |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2025-10-15 |
P190023-S028 |
FlexNav Delivery System; Navitor Transcatheter Aortic Valves |
30-Day Notice |
NPT |
— |
— |
| 2025-10-09 |
P160054-S113 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-10-06 |
P160054-S104 |
HeartMate 3 Left Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2025-10-04 |
P240042-S002 |
Tendyne Transcatheter Mitral Valve System |
Normal 180 Day Track No User Fee |
NPU |
Prosthesis, Mitral Valve, Percutaneously Delivered |
Unknown |
| 2025-09-30 |
P230007-S017 |
TriClip G4 Delivery System; TriClip G5 Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2025-09-30 |
P150035-S032 |
AVEIR Leadless Pacemaker Real-time Clock (RTC) electrical test |
30-Day Notice |
PNJ |
— |
— |
| 2025-09-30 |
P100009-S080 |
MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-09-26 |
P230036-S015 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2025-09-26 |
P150004-S088 |
Proclaim DRG System |
Real-Time Process |
PMP |
— |
— |
| 2025-09-26 |
P140009-S122 |
Infinity DBS System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-09-26 |
P010032-S241 |
Proclaim SCS System |
Real-Time Process |
LGW |
— |
— |
| 2025-09-25 |
P150004-S091 |
DRG Neurostimulation System |
30-Day Notice |
PMP |
— |
— |
| 2025-09-25 |
P140009-S125 |
DBS Neurostimulation System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-09-25 |
P010032-S244 |
SCS Neurostimulation System |
30-Day Notice |
LGW |
— |
— |
| 2025-09-24 |
P150035-S028 |
AVEIR Patient Transmitter (model, LSRM01), AVEIR Patient Transmitter Software (model, LSRM1000 v 1.0), AVEIR Patient T |
Normal 180 Day Track |
OSR |
Pacemaker/Icd/Crt Non-Implanted Components |
Unknown |
| 2025-09-24 |
P100045-S079 |
CardioMEMS HF System |
Special (Immediate Track) |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2025-09-22 |
P190023-S027 |
Navitor Transcatheter Aortic Valve Implantation System |
30-Day Notice |
NPT |
— |
— |
| 2025-09-18 |
P200049-S012 |
Amplatzer Amulet Left Atrial Appendage Occluder |
Real-Time Process |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-09-17 |
P150035-S030 |
Aveir VR Delivery Catheter LSCD111; Aveir DR Delivery Catheter LSCD201 |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2025-09-17 |
P100045-S085 |
CARDIOMEMS HF PRESSURE MEASUREMENT SYSTEM |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2025-09-10 |
P100045-S084 |
CardioMEMSTM HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2025-09-07 |
P140009-S121 |
Liberta RC DBS IPG |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-09-07 |
P010032-S240 |
Eterna SCS IPG |
Normal 180 Day Track |
LGW |
— |
— |
| 2025-09-05 |
P150035-S031 |
AVEIR Leadless Pacemaker |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2025-08-29 |
P230036-S014 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2025-08-29 |
P150004-S089 |
Proclaim Doral Root Ganglion (DRG) IPG |
30-Day Notice |
PMP |
— |
— |
| 2025-08-29 |
P140009-S123 |
Infinity Deep Brain Stimulation (DBS) IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-08-29 |
P010032-S242 |
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2025-08-27 |
P960030-S081 |
IsoFlex (1944) |
Real-Time Process |
NVN |
— |
— |
| 2025-08-27 |
P910023-S479 |
Avant DR CDDRA700Q, CDDRA700T; Gallant DR CDDRA500Q, CDDRA500T; Entrant DR CDDRA300Q, CDDRA300T; Neutrino NxT DR CDD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-08-27 |
P160054-S110 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-08-27 |
P030054-S436 |
Quartet 1456Q, 1457Q, 1458Q, 1458QL; Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Gallant HF CDHFA500B, CDHFA |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-08-26 |
P160054-S111 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-08-20 |
P230007-S015 |
TriClip G5 Delivery System |
Special (Immediate Track) |
NPS |
— |
— |
| 2025-08-20 |
P100009-S078 |
MitraClip G5 Delivery System |
Special (Immediate Track) |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-08-18 |
P230007-S016 |
TriClip Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2025-08-18 |
P100009-S079 |
MitraClip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-08-15 |
P150035-S029 |
AVEIR AR 2 LSP203A Leadless Pacemaker (LP) (atrial) |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2025-08-08 |
P230036-S013 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
Normal 180 Day Track No User Fee |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2025-08-07 |
P220013-S021 |
TactiFlex Ablation Catheter, Sensor Enabled |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-08-04 |
P910023-S481 |
Avant VR (CDVRA700Q, CDVRA700T); Neutrino NxT VR (CDVRA800Q, CDVRA800T CDVRA600Q, CDVRA600T); Gallant VR (CDVRA500Q, |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-08-04 |
P030054-S438 |
Avant (CDHFA700Q, CDHFA700T); Neutrino NxT (CDHFA800Q, CDHFA800T CDHFA600Q, CDHFA600T); Gallant (CDHFA500Q, CDHFA500T); |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-08-01 |
P220013-S020 |
TactiFlex Ablation Catheter, Sensor Enabled |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-07-29 |
P240042-S001 |
Tendyne Transcatheter Mitral Valve |
30-Day Notice |
NPU |
Prosthesis, Mitral Valve, Percutaneously Delivered |
Unknown |
| 2025-07-29 |
P190023-S026 |
Navitor Transcatheter Aortic Valve |
30-Day Notice |
NPT |
— |
— |
| 2025-07-29 |
P040021-S059 |
Epic Plus Stented Tissue Valve; Epic Max Stented Tissue Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2025-07-28 |
P140009-S118 |
Liberta RC DBS IPG (Model 62400) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-07-28 |
P100045-S083 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2025-07-28 |
P010032-S236 |
Eterna SCS IPG (Model 32400) |
Real-Time Process |
LGW |
— |
— |
| 2025-07-25 |
P230036-S012 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2025-07-23 |
P150004-S087 |
Proclaim DRG IPG |
30-Day Notice |
PMP |
— |
— |
| 2025-07-23 |
P100009-S077 |
MitraClip G5 Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-07-17 |
P160054-S109 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-07-17 |
P060040-S120 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-07-11 |
P160054-S108 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2025-07-02 |
P150035-S024 |
Aveir VR and DR Delivery Catheters |
Real-Time Process |
PNJ |
— |
— |
| 2025-07-02 |
P150004-S086 |
Proclaim DRG IPG |
30-Day Notice |
PMP |
— |
— |
| 2025-07-02 |
P140009-S120 |
Infinity DBS IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-07-02 |
P010032-S239 |
Proclaim SCS IPG |
30-Day Notice |
LGW |
— |
— |
| 2025-07-01 |
P160054-S107 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-06-27 |
P230036-S011 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
Real-Time Process |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2025-06-25 |
P230007-S013 |
TriClip G4 Delivery System; MitraClip G5 Delivery System, TriClip G5 Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2025-06-25 |
P100009-S075 |
MitraClip G4 Clip Delivery System; MitraClip NTR Clip Delivery System; MitraClip XTR Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-06-24 |
P140009-S119 |
Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-06-24 |
P010032-S238 |
Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2025-06-20 |
P220013-S019 |
TactiFlex Ablation Catheter, Sensor Enabled |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-06-18 |
P960030-S082 |
IsoFlex Optim Lead 1944, 1948 |
30-Day Notice |
NVN |
— |
— |
| 2025-06-18 |
P960013-S130 |
OptiSense 1999; Tendril SDX Lead 1688T/TC DTB; Tendril ST Lead 1888TC, 1882TC; Tendril STS Lead 2088TC; Tendril STS Lead |
30-Day Notice |
NVN |
— |
— |
| 2025-06-18 |
P950022-S149 |
Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210, |
30-Day Notice |
— |
— |
— |
| 2025-06-18 |
P910023-S480 |
Gallant DR CDDRA500Q; Gallant VR CDVRA500Q; Neutrino NxT DR CDDRA800Q; Neutrino NxT DR CDDRA600Q; Neutrino NxT VR CDVRA8 |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-06-18 |
P880086-S344 |
P880086 Endurity PM1162, PM2162; Endurity Core PM1140, PM2140; AV Plus Dx Lead 1368; Verity ADx XL 5357M/S, 5356, 5256, |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2025-06-18 |
P150035-S027 |
Aveir LSP112V, LSP201A, LSP202V |
30-Day Notice |
— |
— |
— |
| 2025-06-18 |
P140033-S099 |
Endurity MRI PM1172, PM2172; Assurity MRI PM1272, PM2272; Zenex MRI PM1282, PM2282; Zenus MRI PM1182, PM2182; Accent MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-06-18 |
P030054-S437 |
Avant HF CDHFA700B, CDHFA700D, CDHFA700Q, CDHFA700T; Entrant HF CDHFA300B, CDHFA300D, CDHFA300Q, CDHFA300T; Gallant HF C |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-06-18 |
P030035-S210 |
Allure PM3120; Allure Quadra RF PM3242; Allure Quadra PM3140; Allure RF PM3222; Anthem PM3210; Quadra Allure PM3542; |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2025-06-17 |
P970013-S097 |
Microny family of Pacemakers |
Normal 180 Day Track |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2025-06-17 |
P910023-S477 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-06-17 |
P880086-S342 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2025-06-17 |
P150035-S023 |
Aveir Leadless System |
Normal 180 Day Track |
PNJ |
— |
— |
| 2025-06-17 |
P140033-S096 |
Assurity MRI, Endurity MRI family of Pacemakers |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-06-17 |
P030054-S433 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-06-17 |
P030035-S208 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2025-06-09 |
P140009-S116 |
Liberta RC Deep Brain Stimulation Implantable Pulse Generator |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-06-09 |
P010032-S234 |
Eterna Spinal Cord Stimulation Implantable Pulse Generator |
Normal 180 Day Track |
LGW |
— |
— |
| 2025-06-04 |
P160054-S101 |
HeartMate 3 Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2025-06-04 |
P060040-S116 |
HeartMate II Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2025-05-23 |
P240042 |
Tendyne Transcatheter Mitral Valve System |
Original |
NPU |
Prosthesis, Mitral Valve, Percutaneously Delivered |
Unknown |
| 2025-05-23 |
P160054-S100 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2025-05-23 |
P060040-S115 |
HeartMate II Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2025-05-22 |
P970013-S098 |
Microny II SR+ |
30-Day Notice |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2025-05-22 |
P960030-S079 |
IsoFlex |
30-Day Notice |
NVN |
— |
— |
| 2025-05-22 |
P960013-S128 |
Tendril STS, Optisense |
30-Day Notice |
NVN |
— |
— |
| 2025-05-22 |
P950022-S147 |
Durata, Optisure |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-05-22 |
P910023-S478 |
Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR, Ellipse VR, Ellips |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-05-22 |
P880086-S343 |
Zephyr XL DR, Zephyr DR, Zephyr SR, Zephyr XL SR, Verity ADX XL VDR |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2025-05-22 |
P150035-S025 |
Aveir VR |
30-Day Notice |
PNJ |
— |
— |
| 2025-05-22 |
P140033-S097 |
Endurity MRI, Assurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-05-22 |
P030054-S434 |
Avant HF, Avant HF, Gallant HF, Entrant HF, Quadra Assura MP, Quadra Assura, Unify Assura, Quartet, QuickFlex Micro |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-05-22 |
P030035-S209 |
Allure RF, Quadra Allure, Quadra Allure MP, Quadra Allure MP RF |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2025-05-21 |
P160054-S106 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-05-21 |
P060040-S119 |
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
30-Day Notice |
DSQ |
— |
— |
| 2025-05-18 |
P230007-S012 |
TriClip G4 Delivery System;TriClip G5 Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2025-05-18 |
P100009-S074 |
MitraClip G4 Clip Delivery System; MitraClip G5 Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-05-16 |
P140009-S117 |
DBS System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-05-16 |
P010032-S235 |
SCS System |
30-Day Notice |
LGW |
— |
— |
| 2025-05-15 |
P100045-S081 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2025-05-09 |
P230007-S010 |
TriClip G4 System |
Real-Time Process |
NPS |
— |
— |
| 2025-05-09 |
P100009-S071 |
MITRACLIP DELIVERY SYSTEM |
Real-Time Process |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-05-08 |
P160054-S105 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2025-05-08 |
P060040-S118 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-05-07 |
P190023-S025 |
Navitor Transcatheter Aortic Valve Implantation System |
Normal 180 Day Track |
NPT |
— |
— |
| 2025-05-06 |
P110016-S090 |
FlexAbility Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-05-06 |
P100009-S072 |
MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-04-22 |
P200049-S009 |
Amplatzer Amulet Left Atrial Appendage Occluder |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-04-18 |
P230007-S011 |
TriClip Systems |
30-Day Notice |
NPS |
— |
— |
| 2025-04-18 |
P100009-S073 |
MitraClip Systems |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-04-16 |
P230036-S010 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
Normal 180 Day Track No User Fee |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2025-04-15 |
P910023-S476 |
Avant CDVRA700Q, CDVRA700T Neutrino NxT CDVRA800Q, CDVRA800T, CDVRA600Q, CDVRA600T, Gallant CDVRA500Q, CDVRA500T Entrant |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-04-15 |
P030054-S432 |
Avant CDHFA700Q, CDHFA700T; Neutrino NxT CDHFA800Q, CDHFA800T, CDHFA600Q, CDHFA600T; Gallant CDHFA500Q, CDHFA500T; Entra |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-04-14 |
P160054-S103 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-04-14 |
P060040-S117 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-04-11 |
P220013-S018 |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-04-10 |
P220013-S017 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-04-10 |
P110016-S088 |
FlexAbility Ablation Catheter; FlexAbility Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2025-04-07 |
P160054-S102 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-04-03 |
P150035-S022 |
Aveir VR Leadless System |
30-Day Notice |
PNJ |
— |
— |
| 2025-04-01 |
P970013-S094 |
Microny family of Pacemakers |
Normal 180 Day Track |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2025-04-01 |
P910023-S461 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II+/Avant/Neutrino NxT/Gallant/Ent |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-04-01 |
P880086-S333 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2025-04-01 |
P140033-S084 |
Assurity MRI, Endurity MRI family of Pacemakers |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-04-01 |
P030054-S416 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-04-01 |
P030035-S198 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2025-03-27 |
P200049-S011 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-03-27 |
P000039-S082 |
Amplatzer Septal Occluder; Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
MLV |
— |
— |
| 2025-03-18 |
P160054-S099 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-03-13 |
P140009-S115 |
BRIO NEUROSTIMULATION SYSTEM |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-03-13 |
P010032-S233 |
GENESIS AND EON FAMILY NEUROSTIMULATION (IPG) SYSTEMS |
30-Day Notice |
LGW |
— |
— |
| 2025-03-12 |
P160054-S098 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-03-12 |
P150004-S082 |
Dorsal Root Ganglion (DRG) External Pulse Generator (EPG) |
Real-Time Process |
PMP |
— |
— |
| 2025-03-12 |
P150004-S074 |
SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 50cm, SlimTip Dorsal Root Ganglion (DRG) Trial Lead Kit, 90cm, Slim |
Normal 180 Day Track |
PMP |
— |
— |
| 2025-03-12 |
P140009-S113 |
Deep Brain Stimulation (DBS) External Pulse Generator (EPG) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-03-12 |
P010032-S231 |
Spinal Cord Stimulation (SCS) External Pulse Generator (EPG) |
Real-Time Process |
LGW |
— |
— |
| 2025-03-05 |
P220013-S011 |
TactiFlex Ablation Catheter, Sensor Enabled |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2025-03-05 |
P200049-S010 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2025-03-05 |
P000039-S081 |
Amplatzer Septal Occluder |
30-Day Notice |
MLV |
— |
— |
| 2025-02-26 |
P160054-S097 |
HeartMate 3 (HM3) Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-02-26 |
P060040-S114 |
HeartMate II (HMII) Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-02-21 |
P150004-S083 |
Proclaim Dorsal Root Ganglion (DRG) IPG |
30-Day Notice |
PMP |
— |
— |
| 2025-02-21 |
P140009-S114 |
Infinity Deep Brain Stimulation (DBS) IPG; Liberta RC DBS IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-02-21 |
P010032-S232 |
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG); Eterna SCS IPG |
30-Day Notice |
LGW |
— |
— |
| 2025-02-20 |
P810002-S124 |
Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield |
Real-Time Process |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2025-02-18 |
P160054-S096 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-02-18 |
P060040-S113 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-02-13 |
P910023-S475 |
Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-02-13 |
P160054-S095 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2025-02-13 |
P030054-S431 |
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-02-10 |
P230007-S009 |
TriClip G4 System, TriClip G5 Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2025-02-10 |
P100009-S070 |
MitraClip NTR/XTR Clip Delivery System, MitraClip G4 System, MitraClip G5 Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2025-02-06 |
P100045-S077 |
CardioMEMS HF System |
Normal 180 Day Track |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2025-02-05 |
P970013-S096 |
Microny family of Pacemakers |
Normal 180 Day Track |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2025-02-05 |
P960013-S127 |
Tendril STS, UltiPace |
Normal 180 Day Track |
NVN |
— |
— |
| 2025-02-05 |
P950022-S146 |
Durata, Optisure |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-02-05 |
P910023-S470 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2025-02-05 |
P880086-S339 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2025-02-05 |
P150035-S017 |
Aveir Leadless System |
Normal 180 Day Track |
PNJ |
— |
— |
| 2025-02-05 |
P140033-S093 |
Tendril MRI, Assurity MRI, Endurity MRI family of Pacemakers |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2025-02-05 |
P030054-S426 |
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assu |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2025-02-05 |
P030035-S205 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2025-01-16 |
P150035-S021 |
Aveir VR Leadless Pacemaker, Aveir DR Leadless Pacemaker |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2025-01-13 |
P150004-S079 |
Proclaim Dorsal Root Ganglion (DRG) IPG |
Real-Time Process |
PMP |
— |
— |
| 2025-01-13 |
P140009-S109 |
Infinity Deep Brain Stimulation (DBS) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2025-01-13 |
P010032-S227 |
Proclaim Spinal Cord Simulation Implantable Pulse Generator (IPG) |
Real-Time Process |
LGW |
— |
— |
| 2025-01-06 |
P190023-S024 |
Navitor Transcatheter Aortic Valve Implantation (TAVI) System |
Real-Time Process |
NPT |
— |
— |
| 2024-12-31 |
P230007-S005 |
TriClip G5 Delivery System |
Normal 180 Day Track |
NPS |
— |
— |
| 2024-12-31 |
P100009-S067 |
MitraClip G5 System |
Normal 180 Day Track |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-12-20 |
P910023-S455 |
Avant VR, Avant DR, Neutrino NxT VR, Neutrino NxT DR, Gallant VR, Gallant DR, Entrant VR, Entrant DR |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-12-20 |
P150004-S080 |
NeuroSphere Digital Health Apps |
Real-Time Process |
PMP |
— |
— |
| 2024-12-20 |
P140009-S111 |
Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-20 |
P140009-S110 |
Liberta RC Deep Brain Stimulation (DBS) and NeuroSphere Digital Health App |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-20 |
P140009-S103 |
Liberta RC Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-20 |
P030054-S408 |
Avant HF, Neutrino NxT HF, Gallant HF, Neutrino NxT HF, Entrant HF |
135 Review Track For 30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-12-20 |
P010032-S229 |
Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Real-Time Process |
LGW |
— |
— |
| 2024-12-20 |
P010032-S228 |
Eterna Spinal Cord Simulation Implantable Pulse Generator (IPG) and NeuroSphere Digital Health App |
Real-Time Process |
LGW |
— |
— |
| 2024-12-20 |
P010032-S222 |
Eterna Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2024-12-19 |
P910023-S474 |
Avant, Neutrino NxT, Gallant, Entrant |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-12-19 |
P880086-S341 |
Assurity, Assurity +, Endurity, Endurity Core, Endurity, Endurity Core, Zenus, Zenex |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-12-19 |
P140033-S095 |
Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-19 |
P030054-S430 |
Avant, Neutrino NxT, Gallant, Entrant |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-12-19 |
P030035-S207 |
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-12-18 |
P970013-S095 |
Microny family of Pacemakers |
Real-Time Process |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2024-12-18 |
P910023-S469 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-12-18 |
P880086-S338 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-12-18 |
P230036-S008 |
ESPRIT BTK Everolimus Eluting Bioresorbable Scaffold System |
Real-Time Process |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-12-18 |
P160054-S093 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-12-18 |
P150035-S016 |
Aveir Leadless System |
Real-Time Process |
PNJ |
— |
— |
| 2024-12-18 |
P140033-S092 |
Assurity MRI, Endurity MRI family of Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-12-18 |
P060040-S111 |
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
30-Day Notice |
DSQ |
— |
— |
| 2024-12-18 |
P030054-S425 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-12-18 |
P030035-S204 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Real-Time Process |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-12-17 |
P160054-S092 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-12-17 |
P150035-S019 |
Aveir VR Leadless System |
Real-Time Process |
PNJ |
— |
— |
| 2024-12-17 |
P060040-S110 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-12-13 |
P200049-S008 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-12-13 |
P150004-S081 |
Axium Neurostimulator System |
30-Day Notice |
PMP |
— |
— |
| 2024-12-13 |
P140009-S112 |
Deep Brain Stimulation (DBS) Extensions & Adapters |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-13 |
P120021-S026 |
Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2024-12-13 |
P110016-S087 |
FlexAbility Ablation Catheter (Flex) and FlexAbility Ablation Catheter, Sensor Enabled (Flex SE) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2024-12-13 |
P040040-S049 |
Amplatzer Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2024-12-13 |
P030054-S429 |
Avant HF, Entrant HF, Gallant HF, Neutrino NxT HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-12-13 |
P020024-S070 |
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2024-12-13 |
P010032-S230 |
Spinal Cord Stimulation (SCS) Leads, Extensions, & Adapters |
30-Day Notice |
LGW |
— |
— |
| 2024-12-13 |
P000039-S080 |
Amplatzer Septal Occluder, Amplatzer Multifenestrated Septal Occluder Cribriform |
30-Day Notice |
MLV |
— |
— |
| 2024-12-11 |
P230036-S007 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
Normal 180 Day Track No User Fee |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-12-10 |
P230036-S009 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-12-06 |
P100045-S080 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-12-03 |
P160054-S087 |
HeartMate 3 Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit |
Real-Time Process |
DSQ |
— |
— |
| 2024-12-03 |
P150004-S077 |
Proclaim Doral Root Ganglion (DRG) IPG |
Real-Time Process |
PMP |
— |
— |
| 2024-12-03 |
P140009-S107 |
Infinity Deep Brain Stimulation (DBS) IPG |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-12-03 |
P060040-S109 |
HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit |
Real-Time Process |
DSQ |
— |
— |
| 2024-12-03 |
P010032-S226 |
Proclaim Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Real-Time Process |
LGW |
— |
— |
| 2024-11-27 |
P220013-S015 |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-11-25 |
P230007-S008 |
TriClip G4 Clip Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2024-11-25 |
P100009-S069 |
MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-11-22 |
P910023-S473 |
Avant, Entrant, Fortify, Fortify Assura, Gallant, Neutrino NxT |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-11-22 |
P220013-S014 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-11-22 |
P150035-S020 |
Aveir Leadless Pacemaker- Right Atrial, Aveir Leadless Pacemaker- Right Ventricular, |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2024-11-22 |
P030054-S428 |
Avant, Entrant, Gallant, Neutrino NxT, Quadra Assura, Unify, Unify Assura, Unify Quadra |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-11-22 |
P010032-S217 |
SCS EPG 2-Port Header (Model 3042) |
Normal 180 Day Track |
LGW |
— |
— |
| 2024-11-19 |
P160054-S091 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2024-11-19 |
P160054-S089 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-11-18 |
P160054-S090 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-11-15 |
P100045-S078 |
CardioMEMS HF System |
Special (Immediate Track) |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-11-14 |
P160054-S088 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-11-13 |
P230007-S007 |
TriClip G4 System |
Normal 180 Day Track No User Fee |
NPS |
— |
— |
| 2024-11-13 |
P140009-S106 |
Liberta RC DBS Charging System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-11-13 |
P010032-S225 |
Eterna SCS Charging System |
Real-Time Process |
LGW |
— |
— |
| 2024-11-01 |
P040040-S048 |
Amplatzer Muscular VSD Occluder |
Normal 180 Day Track No User Fee |
MLV |
— |
— |
| 2024-10-28 |
P910023-S472 |
Avant, Neutrino NxT, Gallant, Entrant, Fortify VR, Fortify DR, Ellipse VR, Ellipse DR, Fortify Assura VR, Fortify A |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-28 |
P880086-S340 |
Assurity, Assurity +, Endurity, Endurity Core, Zenus, Zenex, Accent |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-10-28 |
P140033-S094 |
Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-28 |
P030054-S427 |
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, Avant, Neutrino NxT, Gallant, Entrant |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-10-28 |
P030035-S206 |
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP, Anthem |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-10-24 |
P150004-S078 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2024-10-24 |
P140009-S108 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-10-22 |
P230007-S006 |
TriClip G4 Clip Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2024-10-22 |
P190023-S023 |
Navitor Titan Valve |
30-Day Notice |
NPT |
— |
— |
| 2024-10-22 |
P100009-S068 |
MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-10-17 |
P150035-S018 |
Aveir VR Delivery Catheter |
30-Day Notice |
PNJ |
— |
— |
| 2024-10-17 |
P040021-S054 |
Epic Plus, Epic Max Tissue Heart Valves |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-10-11 |
P910023-S463 |
Merlin.net MN5000 |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-11 |
P880086-S334 |
Merlin.net MN5000 |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-10-11 |
P150035-S007 |
AVEIR Patient Transmitter, AVEIR Patient Transmitter Software, AVEIR Patient Trasmitter Wired Electrodes, Merlin.net |
Normal 180 Day Track |
PNJ |
— |
— |
| 2024-10-11 |
P140033-S086 |
Merlin.net MN5000 |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-10-11 |
P030054-S418 |
Merlin.net MN5000 |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-10-11 |
P030035-S199 |
Merlin.net MN5000 |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-10-09 |
P220013-S013 |
TactiFlex Ablation Catheter, Sensor Enabled, TactiCath Contact Force Ablation Catheter, Sensor Enabled |
Real-Time Process |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-10-08 |
P150004-S069 |
Axium Neurostimulator System |
Normal 180 Day Track No User Fee |
PMP |
— |
— |
| 2024-10-08 |
P140009-S093 |
Brio Neurostimulation System |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-10-08 |
P010032-S211 |
Genesis Neurostimulation System |
Normal 180 Day Track No User Fee |
LGW |
— |
— |
| 2024-10-03 |
P910023-S471 |
Ellipse DR, Ellipse VR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-10-01 |
P200049-S007 |
Amplatzer Amulet Left Atrial Appendage Occluder |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-10-01 |
P190023-S020 |
FlexNav and Navitor Loading System, FlexNav Delivery System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2024-10-01 |
P120021-S025 |
Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder |
Normal 180 Day Track No User Fee |
MLV |
— |
— |
| 2024-10-01 |
P040040-S047 |
Amplatzer Muscular VSD Occluder |
Normal 180 Day Track No User Fee |
MLV |
— |
— |
| 2024-10-01 |
P020024-S069 |
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder |
Normal 180 Day Track No User Fee |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2024-10-01 |
P000039-S079 |
Amplatzer Septal Occluder, Amplatzer Multifenestrated Septal Occluder Cribriform |
Normal 180 Day Track No User Fee |
MLV |
— |
— |
| 2024-09-30 |
P190023-S022 |
Navitor Transcatheter Aortic Heart Valves |
30-Day Notice |
NPT |
— |
— |
| 2024-09-27 |
P160054-S083 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2024-09-26 |
P960030-S078 |
IsoFlex |
Real-Time Process |
NVN |
— |
— |
| 2024-09-26 |
P960013-S126 |
Tendril STS, UltiPace |
Real-Time Process |
NVN |
— |
— |
| 2024-09-26 |
P150035-S014 |
Aveir VR Leadless Pacemaker: AveirLeadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker: Aveir Leadless |
Normal 180 Day Track |
PNJ |
— |
— |
| 2024-09-26 |
P030054-S424 |
Quartet |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-09-26 |
P030035-S203 |
Quadra Allure, Quadra Allure MP |
Real-Time Process |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-09-25 |
P910023-S468 |
Aveir Leadless System (Dual-Chamber) |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-09-25 |
P880086-S337 |
Aveir Leadless System (Dual-Chamber) |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-09-25 |
P150035-S013 |
Aveir Leadless System (Dual-Chamber) |
Normal 180 Day Track |
PNJ |
— |
— |
| 2024-09-25 |
P140033-S091 |
Aveir Leadless System (Dual-Chamber) |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-09-25 |
P030054-S423 |
Aveir Leadless System (Dual-Chamber) |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-09-25 |
P030035-S202 |
Aveir Leadless System (Dual-Chamber) |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-09-23 |
P160054-S082 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2024-09-18 |
P160054-S086 |
HeartMate 3 Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit |
30-Day Notice |
DSQ |
— |
— |
| 2024-09-18 |
P140009-S105 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-09-18 |
P060040-S108 |
HeartMate II Left Ventricular Assist System (LVAS), HeartMate Mobile Power Unit |
30-Day Notice |
— |
— |
— |
| 2024-09-18 |
P010032-S224 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2024-09-11 |
P160054-S085 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-09-11 |
P060040-S107 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-08-29 |
P150035-S015 |
Aveir VR Delivery Catheter, Aveir DR Delivery Catheter |
Normal 180 Day Track No User Fee |
PNJ |
— |
— |
| 2024-08-29 |
P100045-S076 |
CardioMEMS HF System |
Normal 180 Day Track No User Fee |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-08-28 |
P230036-S006 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-08-28 |
P160054-S084 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-08-28 |
P060040-S106 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-08-23 |
P230036-S004 |
ESPRIT BTK Everolimus Eluting Bioresorbable Scaffold System |
Real-Time Process |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-08-23 |
P150004-S076 |
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2024-08-23 |
P140009-S104 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-08-23 |
P010032-S223 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2024-08-15 |
P810002-S122 |
Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) |
Real-Time Process |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2024-08-08 |
P140009-S102 |
Deep Brain Stimulation (DBS) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-08-08 |
P010032-S221 |
Spinal Cord Stimulation (SCS) |
30-Day Notice |
LGW |
— |
— |
| 2024-08-02 |
P910023-S467 |
Avant, Entrant, Gallant, Neutrino NxT |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-08-02 |
P140009-S099 |
Clinician Programmer Application Version 2.0.2, and Liberta RC DBS IPG Firmware Version 1.1.1 |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-08-02 |
P030054-S422 |
Avant, Entrant, Gallant, Neutrino NxT |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-08-02 |
P010032-S218 |
Patient Controller Application Version 2.0.2 |
Real-Time Process |
LGW |
— |
— |
| 2024-07-31 |
P140009-S100 |
Liberta RC DBS IPG |
Special (Immediate Track) |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-07-31 |
P010032-S219 |
Eterna SCS IPG |
Special (Immediate Track) |
LGW |
— |
— |
| 2024-07-26 |
P230036-S005 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-07-26 |
P160054-S074 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2024-07-26 |
P140009-S101 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-07-26 |
P010032-S220 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2024-07-25 |
P040021-S058 |
Epic Plus Tissue Heart Valves, Epic Max Tissue Heart Valves, Epic Tissue Heart Valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-07-24 |
P150004-S073 |
Axium Neurostimulator System |
Real-Time Process |
PMP |
— |
— |
| 2024-07-24 |
P140009-S098 |
Brio Neurostimulation System |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-07-24 |
P010032-S216 |
Genesis and EON Family Neurostimulation (IPG) System |
Real-Time Process |
LGW |
— |
— |
| 2024-07-21 |
P220013-S012 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-07-17 |
P150004-S075 |
DRG Delivery Sheath |
30-Day Notice |
PMP |
— |
— |
| 2024-07-16 |
P160054-S081 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-07-16 |
P100009-S066 |
MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-07-16 |
P060040-S105 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-07-12 |
P150035-S012 |
Aveir VR Leadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker (Right Ventricular) |
30-Day Notice |
PNJ |
— |
— |
| 2024-07-02 |
P810002-S123 |
Masters Series Aortic Valved Graft with Hemashield Graft Technology (CAVGJ) |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2024-07-02 |
P140033-S089 |
The Tendril MRI lead |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-06-26 |
P200049-S006 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2024-06-26 |
P150004-S071 |
Family of DRG IPGs |
Normal 180 Day Track |
PMP |
— |
— |
| 2024-06-26 |
P140009-S095 |
Family of DBS IPGs |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-06-26 |
P120021-S024 |
Amplatzer PFO Occluder, Amplatzer Talisman PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2024-06-26 |
P040040-S046 |
Amplatzer Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2024-06-26 |
P020024-S068 |
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2024-06-26 |
P010032-S213 |
Family of SCS IPGs |
Normal 180 Day Track |
LGW |
— |
— |
| 2024-06-26 |
P000039-S078 |
Amplatzer Multifenestrated Septal Occluder Cribriform |
30-Day Notice |
MLV |
— |
— |
| 2024-06-25 |
P220013-S002 |
TactiFlex Ablation Catheter, Sensor Enabled |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2024-06-21 |
P230036-S003 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
Normal 180 Day Track No User Fee |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-06-20 |
P230007-S002 |
TriClip G4 Delivery System |
Real-Time Process |
NPS |
— |
— |
| 2024-06-20 |
P100009-S065 |
MitraClip G4 Clip Delivery System |
Real-Time Process |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-06-12 |
P960013-S125 |
UltiPace Pacing Lead, Tendril STS Pacing Lead |
30-Day Notice |
NVN |
— |
— |
| 2024-06-12 |
P140033-S090 |
Tendril MRI Pacing Lead |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-06-06 |
P150035-S011 |
Aveir Delivery Catheter |
30-Day Notice |
PNJ |
— |
— |
| 2024-05-31 |
P230007-S004 |
TriClip G4 System |
Normal 180 Day Track No User Fee |
NPS |
— |
— |
| 2024-05-31 |
P230007-S003 |
TriClip G4 System |
Normal 180 Day Track No User Fee |
NPS |
— |
— |
| 2024-05-31 |
P160054-S080 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Special (Immediate Track) |
DSQ |
— |
— |
| 2024-05-31 |
P060040-S104 |
HeartMate II Left Ventricular Assist System (LVAS) |
Special (Immediate Track) |
DSQ |
— |
— |
| 2024-05-30 |
P230036-S002 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-05-30 |
P040021-S057 |
Epic Plus, Epic Plus Supra and Epic Max Valves in the Epic Valve Sterilization Process |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-05-29 |
P230036-S001 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
30-Day Notice |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-05-29 |
P190023-S019 |
Navitor TAVI System |
30-Day Notice |
NPT |
— |
— |
| 2024-05-22 |
P910023-S466 |
Fortify, Fortify Assura, Ellipse |
135 Review Track For 30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-22 |
P030054-S421 |
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP |
135 Review Track For 30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-05-16 |
P150004-S072 |
Dorsal Root Ganglion (DRG) External Pulse Generator (EPG), Proclaim DRG EPG Base |
30-Day Notice |
PMP |
— |
— |
| 2024-05-16 |
P140009-S097 |
Deep Brain Stimulation (DBS) External Pulse Generator (EPG), Infinity DBS EPG Base |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-05-16 |
P010032-S215 |
Spinal Cord Stimulation (SCS) External Pulse Generator (EPG), Proclaim SCS EPG Base |
30-Day Notice |
LGW |
— |
— |
| 2024-05-14 |
P910023-S465 |
Entrant VR ICD, Entrant DR ICD, Gallant VR ICD, Gallant DR ICD Neutrino NxT VR ICD, Neutrino NxT DR ICD |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-14 |
P160054-S079 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2024-05-14 |
P030054-S420 |
Entrant CRT-D, Gallant CRT D, Neutrino NxT HF CRT-D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-05-13 |
P100045-S075 |
CardioMEMS HF System |
Normal 180 Day Track No User Fee |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-05-13 |
P100045-S073 |
CardioMEMS HF System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-05-09 |
P230007-S001 |
TriClip G4 Clip Delivery System |
30-Day Notice |
NPS |
— |
— |
| 2024-05-02 |
P160054-S078 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-05-02 |
P140009-S092 |
Liberta RC DBS IPG |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-05-02 |
P010032-S210 |
Eterna SCS IPG |
Real-Time Process |
LGW |
— |
— |
| 2024-05-01 |
P910023-S464 |
Avant, Gallant, Entrant, Neutrino NxT Family of ICDs |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-05-01 |
P880086-S336 |
Assurity, Assurity+, Endurity, Endurity Core, Zenus, Zenex Family of Pacemakers |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-05-01 |
P150035-S010 |
Aveir VR Delivery Catheter and Aveir DR Delivery Catheter |
30-Day Notice |
PNJ |
— |
— |
| 2024-05-01 |
P140033-S088 |
Assurity MRI, Endurity MRI, Zenus MRI and Zenex MRI Family of Pacemakers |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-05-01 |
P030054-S419 |
Avant, Gallant, Entrant, Neutrino NxT Family of CRT-Ds |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-05-01 |
P030035-S201 |
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure, Quadra Allure MP family of CRT-Ps |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-04-30 |
P140009-S096 |
Liberta RC DBS IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-04-30 |
P010032-S214 |
Eterna SCS IPG |
30-Day Notice |
LGW |
— |
— |
| 2024-04-26 |
P230036 |
Esprit BTK Everolimus Eluting Resorbable Scaffold System |
Original |
NXW |
Scaffold, Infrapopliteal, Absorbable |
Unknown |
| 2024-04-16 |
P160054-S077 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-04-16 |
P060040-S103 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-04-09 |
P100009-S064 |
MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-04-05 |
P150004-S070 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
Special (Immediate Track) |
PMP |
— |
— |
| 2024-04-05 |
P140009-S094 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
Special (Immediate Track) |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-04-05 |
P010032-S212 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Special (Immediate Track) |
LGW |
— |
— |
| 2024-04-04 |
P150035-S009 |
Aveir VR Delivery Catheter, Aveir DR Delivery Catheter |
30-Day Notice |
PNJ |
— |
— |
| 2024-04-03 |
P810002-S121 |
Masters Series, Masters Series HP, Regent, Masters Series Aortic Valved Graft with Hemashield graft technology |
Real-Time Process |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2024-04-02 |
P100045-S074 |
CardioMEMS Hospital System, model CM3100 |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-04-01 |
P230007 |
TriClip G4 System |
Original |
NPS |
— |
— |
| 2024-04-01 |
P160054-S076 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2024-04-01 |
P060040-S102 |
HeartMate II Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2024-03-29 |
P150035-S008 |
Aveir VR Leadless Pacemaker: Aveir Leadless Pacemaker (Right Ventricular), Aveir DR Leadless Pacemaker: Aveir Leadle |
30-Day Notice |
PNJ |
— |
— |
| 2024-03-27 |
P880086-S335 |
Accent, Assurity, Assurity+, Endurity, Endurity Core, Zenex, Zenus |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-03-27 |
P140033-S087 |
Assurity MRI, Endurity MRI,Zenex MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-03-27 |
P030035-S200 |
Anthem,Allure, Allure Quadra, Quadra Allure (MRI Conditional),Quadra Allure MP |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2024-03-26 |
P960013-S124 |
Tendril STS, UltiPace |
Real-Time Process |
NVN |
— |
— |
| 2024-03-26 |
P140033-S085 |
Assurity MRI, Endurity MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-03-21 |
P190023-S018 |
Navitor Transcatheter Aortic Valve, Navitor Loading System , FlexNav Delivery System, Navitor Titan Transcatheter A |
30-Day Notice |
NPT |
— |
— |
| 2024-03-21 |
P060040-S101 |
THORATEC HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM |
30-Day Notice |
DSQ |
— |
— |
| 2024-03-18 |
P950022-S145 |
TVL(TM) Lead System |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-03-06 |
P150035-S006 |
Aveir Delivery Catheter |
30-Day Notice |
PNJ |
— |
— |
| 2024-02-29 |
P160054-S075 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-02-29 |
P160054-S069 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2024-02-29 |
P060040-S100 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2024-02-28 |
P880086-S332 |
Endurity, Assurity, Endurity Core, Zenus, Zenex |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2024-02-28 |
P140033-S083 |
Assurity MRI, Endurity MRI, Zenus MRI, Zenex MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2024-02-22 |
P160054-S073 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2024-02-21 |
P910023-S462 |
Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura, Fortify |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2024-02-21 |
P160054-S072 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2024-02-21 |
P140009-S084 |
DBS System - Lead and Extension |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-02-21 |
P030054-S417 |
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2024-02-14 |
P100009-S063 |
MitraClip G4 System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-02-02 |
P160054-S064 |
HeartMate 3 Left Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2024-02-02 |
P140009-S091 |
Infinity Deep Brain Stimulation (DBS) Leads |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-02-02 |
P010032-S209 |
Spinal Cord Stimulation (SCS) Leads |
30-Day Notice |
LGW |
— |
— |
| 2024-01-31 |
P160054-S070 |
HeartMate 3 Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2024-01-31 |
P100045-S072 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-01-31 |
P060040-S098 |
HeartMate II Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2024-01-24 |
P140009-S087 |
Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2024-01-24 |
P010032-S202 |
Liberta RC DBS IPG ,Charger Kit - Pectoral ,Patient Controller Application ,Clinician Programmer Application |
Normal 180 Day Track |
LGW |
— |
— |
| 2024-01-23 |
P040021-S056 |
Epic Plus and Epic Plus Supra |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2024-01-22 |
P150004-S065 |
DRG System - Leads and Extensions |
135 Review Track For 30-Day Notice |
PMP |
— |
— |
| 2024-01-22 |
P100009-S061 |
MitraClip G4 Clip Delivery System |
Normal 180 Day Track |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2024-01-19 |
P100045-S071 |
CardioMEMS HF System |
Special (Immediate Track) |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2024-01-11 |
P160054-S056 |
HeartMate 3 Left Ventricular Assist System |
135 Review Track For 30-Day Notice |
DSQ |
— |
— |
| 2024-01-10 |
P150004-S068 |
Dorsal Root Ganglion (DRG) SlimTip Trial Lead Kit and DRG SlimTip Implant Lead Kit |
Real-Time Process |
PMP |
— |
— |
| 2023-12-28 |
P160054-S071 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2023-12-28 |
P060040-S099 |
HeartMate II Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2023-12-27 |
P970013-S093 |
Microny |
30-Day Notice |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2023-12-27 |
P910023-S460 |
Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-27 |
P880086-S331 |
Accent, Accent MRI, Assurity, Assurity+, Endurity, Endurity Core |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2023-12-27 |
P140033-S082 |
Endurity MRI, Assurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-12-27 |
P030054-S415 |
Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-12-27 |
P030035-S197 |
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2023-12-23 |
P160054-S066 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2023-12-23 |
P060040-S096 |
HeartMate II Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2023-12-19 |
P150004-S063 |
Proclaim DRG IPG (Model 3664), DRG 50cm leads (models MN10450-50, MN10450-50A), port plug (Model 7108), lead anchor |
Normal 180 Day Track |
PMP |
— |
— |
| 2023-12-19 |
P010032-S206 |
Charger, Model 16000 |
Real-Time Process |
LGW |
— |
— |
| 2023-12-18 |
P190023-S017 |
Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves |
30-Day Notice |
NPT |
— |
— |
| 2023-12-18 |
P040021-S055 |
Epic, Epic Supra, Epic Plus, Epic Plus Supra, Epic Max, Portico, Navitor, and Navitor Titan Tissue Heart Valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-12-14 |
P160054-S068 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-12-14 |
P060040-S097 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-12-04 |
P810002-S119 |
SJM Masters Series Mechanical Heart Valve, 15mm HP |
Normal 180 Day Track No User Fee |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2023-12-01 |
P910023-S459 |
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-12-01 |
P100009-S062 |
MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-12-01 |
P030054-S414 |
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-11-29 |
P950022-S144 |
Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-29 |
P910023-S457 |
Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-11-29 |
P220013-S001 |
Ampere Generator, Ampere Remote Control, Ampere Generator System Kit |
Normal 180 Day Track |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-11-29 |
P110016-S084 |
Ampere Generator, Ampere Remote Control, Ampere Generator System Kit |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-11-29 |
P030054-S412 |
Avant, Neutrino NxT, Gallant, and Entrant (NGQ) ICDs and CRT-Ds DF-1 Model Expansion |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-11-28 |
P960013-S123 |
Tendril STS, UltiPace |
Normal 180 Day Track |
NVN |
— |
— |
| 2023-11-27 |
P150004-S052 |
Proclaim DRG IPG |
Real-Time Process |
PMP |
— |
— |
| 2023-11-20 |
P100009-S055 |
MitraClip G4 Clip Delivery System |
Normal 180 Day Track |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-11-16 |
P160054-S065 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-11-16 |
P060040-S095 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-11-07 |
P190023-S016 |
PorticoTM, NavitorTM, and Navitor Titan Transcatheter Aortic Heart Valves |
30-Day Notice |
NPT |
— |
— |
| 2023-10-31 |
P910023-S458 |
Avant, Neutrino NxT, Gallant, Entrant, Ellipse, Fortify Assura |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-10-31 |
P030054-S413 |
Avant, Neutrino NxT, Gallant, Entrant, Unify, Unify Assura, Quadra Assura |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-10-27 |
P160054-S061 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2023-10-27 |
P140009-S090 |
Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-10-27 |
P100045-S070 |
CardioMEMSTM HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2023-10-27 |
P100009-S060 |
MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-10-27 |
P010032-S207 |
Spinal Cord Stimulation (SCS) Legacy Charger Systems and Accessories |
30-Day Notice |
LGW |
— |
— |
| 2023-10-26 |
P220013-S008 |
TactiFlex Ablation CatTactiFlex Ablation Catheter, Sensor Enabledheter, Sensor Enabled, TactiSys Quartz Equipment, |
Normal 180 Day Track No User Fee |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-10-26 |
P110016-S086 |
FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-10-26 |
P010032-S205 |
Eterna SCS IPG |
30-Day Notice |
LGW |
— |
— |
| 2023-10-25 |
P160054-S063 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2023-10-24 |
P220013-S010 |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-10-24 |
P160054-S062 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-10-24 |
P060040-S094 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-10-20 |
P160054-S060 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-10-20 |
P060040-S093 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-10-18 |
P810002-S120 |
SJM Masters Series Mechanical Heart Valve, SJM Regent Mechanical Heart Valve, SJM Masters Series Aortic Valved Graft |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2023-10-18 |
P040021-S053 |
Epic Supra Valve, Epic Valve, Epic Plus Stented Tissue Valve, Epic Plus Supra Valve, Epic Max Valve |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-10-17 |
P100009-S059 |
MitraClip NTR/XTR Clip Delivery System, MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-10-13 |
P220013-S009 |
TactiFlex SE Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-10-12 |
P100009-S058 |
MitraClip G4 Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-10-05 |
P010032-S200 |
Eterna SCS System |
Real-Time Process |
LGW |
— |
— |
| 2023-09-29 |
P160054-S053 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track No User Fee |
DSQ |
— |
— |
| 2023-09-29 |
P150004-S067 |
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories |
30-Day Notice |
PMP |
— |
— |
| 2023-09-29 |
P140009-S089 |
Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-09-29 |
P060040-S091 |
HeartMate II Left Ventricular Assist System |
Normal 180 Day Track No User Fee |
DSQ |
— |
— |
| 2023-09-29 |
P010032-S204 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories |
30-Day Notice |
LGW |
— |
— |
| 2023-09-27 |
P160054-S059 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-09-22 |
P150004-S066 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2023-09-22 |
P140009-S088 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-09-22 |
P010032-S203 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2023-09-20 |
P910023-S456 |
Fortify, Fortify Assura, Ellipse Family of ICD Devices |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-09-20 |
P880086-S330 |
Accent, Assurity, Assurity+ , Zenus, Zenex, Endurity Family of Pacemakers |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2023-09-20 |
P140033-S081 |
Assurity MRI, Endurity MRI, Accent MRI, Zenus MRI and Zenex MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-09-20 |
P030054-S411 |
Quadra Assura, Unify, Unify Assura and Unify Quadra Family of CRT-D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-09-20 |
P030035-S196 |
Anthem, Allure, Quadra Allure and Allure Quadra Family of CRT-Ps |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2023-09-15 |
P190023-S013 |
Navitor Transcatheter Aortic Valve Implantation System, Navitor Transcatheter Aortic Heart Valve, FlexNav Delivery Syste |
Normal 180 Day Track |
NPT |
— |
— |
| 2023-09-12 |
P160054-S058 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-09-07 |
P220013-S007 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-09-07 |
P220013-S006 |
TactiFlex Ablation Catheter, Sensor Enabled (TactiFlex SE) |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-09-07 |
P160054-S057 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-09-06 |
P100045-S069 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2023-08-30 |
P100009-S057 |
MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-08-25 |
P140009-S086 |
Infinity Deep Brain Stimulation (DBS) System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-08-24 |
P150035-S005 |
Aveir VR and DR Leadless Pacemakers |
30-Day Notice |
PNJ |
— |
— |
| 2023-08-23 |
P100009-S052 |
MitraClip Clip Delivery System |
Normal 180 Day Track No User Fee |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-08-17 |
P220013-S004 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-08-17 |
P110016-S085 |
FlexAbility Ablation Catheter, FlexAbility Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-08-16 |
P220013-S003 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-08-11 |
P220013-S005 |
TactiFlex Ablation Catheter, Sensor Enabled |
30-Day Notice |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-08-09 |
P150004-S064 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2023-08-09 |
P010032-S201 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2023-08-08 |
P030054-S410 |
QuickFlex µ, Quartet |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-07-28 |
P100045-S066 |
CardioMEMS Hospital System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2023-07-27 |
P140009-S081 |
Infinity Deep Brain Stimulation (DBS) System |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-07-27 |
P010032-S195 |
Spinal Cord Stimulation (SCS) System |
135 Review Track For 30-Day Notice |
LGW |
— |
— |
| 2023-07-26 |
P100045-S068 |
CardioMEMS HF System |
Normal 180 Day Track No User Fee |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2023-07-21 |
P150004-S062 |
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generators (IPGs), leads, extensions, and accessories |
30-Day Notice |
PMP |
— |
— |
| 2023-07-21 |
P140009-S085 |
Deep Brain Stimulation (DBS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-07-21 |
P010032-S199 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generators (IPGs), leads, extensions, and accessories |
30-Day Notice |
LGW |
— |
— |
| 2023-07-19 |
P100045-S067 |
CardioMEMSTM HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2023-07-19 |
P030054-S409 |
Neutrino NxT HF, Avant HF, Gallant HF, Entrant HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-07-03 |
P160054-S051 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2023-06-29 |
P150035-S003 |
Aveir DR Leadless System |
Panel Track |
PNJ |
— |
— |
| 2023-06-29 |
P100009-S056 |
MitraClip Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-06-22 |
P160054-S055 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-06-15 |
P910023-S454 |
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-06-15 |
P030054-S407 |
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-06-02 |
P150004-S061 |
Dorsal Root Ganglion Stimulation (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2023-06-02 |
P140009-S083 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-06-02 |
P010032-S198 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2023-05-23 |
P880086-S329 |
Accent, Accent MRI, Assurity, Assurity+, Endurity ,Endurity Core |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2023-05-23 |
P140033-S080 |
Endurity MRI, Assurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-23 |
P030035-S195 |
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2023-05-18 |
P220013 |
TactiFlex Ablation Catheter, Sensor Enabled, TactiSys Quartz Equipment, TactiSys Quartz, TactiFlex Radiofrequency C |
Original |
OAE |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
Unknown |
| 2023-05-11 |
P960013-S122 |
Tendril STS 2088TC, OptiSense Low Voltage Pacing Leads |
Normal 180 Day Track |
NVN |
— |
— |
| 2023-05-10 |
P190023-S015 |
Navitor Transcatheter Aortic Heart Valve |
30-Day Notice |
NPT |
— |
— |
| 2023-05-10 |
P010032-S191 |
Prodigy, Proclaim XR, Proclaim Plus, and Externa Spinal Cord Stimulation (SCS) Systems |
Panel Track |
LGW |
— |
— |
| 2023-05-05 |
P010032-S193 |
Lamitrode Tripole 16 Lead 60cm Length (Model 3219), TriCentrus 16 Lead 60cm Length (Model 3292), Octrode Lead 90cm Lengt |
Normal 180 Day Track |
LGW |
— |
— |
| 2023-05-04 |
P150004-S060 |
Proclaim Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2023-05-04 |
P010032-S197 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2023-05-03 |
P100009-S054 |
MitraClip Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-05-02 |
P200049-S005 |
Amplatzer Amulet (ACP2) |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2023-05-02 |
P110016-S083 |
FlexAbility Ablation Catheter, FlexAbility SE |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-05-02 |
P000039-S077 |
Amplatzer Septal Occluder (ASO/ASD) |
30-Day Notice |
MLV |
— |
— |
| 2023-05-01 |
P910023-S453 |
Ellipse DR, Ellipse VR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-05-01 |
P880086-S328 |
Assurity, Assurity +, Endurity, Endurity Core |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2023-05-01 |
P140033-S079 |
Assurity MRI, Endurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-05-01 |
P030035-S194 |
Allure, Allure RF, Allure Quadra, Allure Quadra RF, Quadra Allure MP, Quadra Allure MP RF |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2023-04-29 |
P160054-S054 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2023-04-29 |
P060040-S092 |
HeartMate II Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2023-04-28 |
P100045-S065 |
CardioMEMS HF System |
Special (Immediate Track) |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2023-04-28 |
P010032-S192 |
Spinal Cord Stimulation (SCS) System |
135 Review Track For 30-Day Notice |
LGW |
— |
— |
| 2023-04-26 |
P190023-S014 |
Navitor Transcatheter Aortic Heart Valve, Portico Transcatheter Aortic Heart Valve, FlexNav Delivery System |
30-Day Notice |
NPT |
— |
— |
| 2023-04-14 |
P970013-S092 |
Microny family of Pacemakers |
Real-Time Process |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2023-04-14 |
P910023-S451 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-04-14 |
P880086-S326 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2023-04-14 |
P150035-S004 |
Aveir VR Leadless Pacemaker |
Real-Time Process |
PNJ |
— |
— |
| 2023-04-14 |
P140033-S077 |
Assurity MRI, Endurity MRI family of Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-04-14 |
P030054-S405 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-04-14 |
P030035-S192 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Real-Time Process |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2023-04-07 |
P150004-S059 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2023-04-07 |
P140009-S082 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2023-04-07 |
P010032-S196 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2023-03-31 |
P810002-S118 |
Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2023-03-30 |
P100009-S053 |
MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-03-28 |
P810002-S117 |
BILEAFLET-CENTER OPENING CARDIAC VALVE |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2023-03-28 |
P040021-S052 |
Epic Max Tissue Heart Valves |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2023-03-27 |
P020024-S067 |
Amplatzer Piccolo Occluder |
Normal 180 Day Track No User Fee |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2023-03-21 |
P060040-S090 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-03-07 |
P160054-S048 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Normal 180 Day Track No User Fee |
DSQ |
— |
— |
| 2023-02-24 |
P110016-S082 |
FlexAbility Ablation Catheter, Sensor Enabled |
Normal 180 Day Track No User Fee |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2023-02-21 |
P910023-S449 |
Ellipse, Fortify, Fortify Assura, Quadra Assura MP |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-02-21 |
P030054-S403 |
Quadra Assura, Unify, Unify Assura, Unify Quadra |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-02-16 |
P160054-S052 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2023-02-10 |
P910023-S452 |
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-02-10 |
P910023-S450 |
Fortify, Fortify Assura, Ellipse, Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avan |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2023-02-10 |
P880086-S327 |
Assurity, Assurity+, Endurity |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2023-02-10 |
P140033-S078 |
Assurity MRI, Endurity MRI, |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2023-02-10 |
P030054-S406 |
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-02-10 |
P030054-S404 |
Unify ,Unify Assura, Quadra Assura, Quadra Assura MP, Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, Neutrino NxT |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2023-02-10 |
P030035-S193 |
Allure, Allure Quadra, Quadra Allure, Quadra Allure MP |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2023-02-07 |
P190023-S012 |
Portico |
30-Day Notice |
NPT |
— |
— |
| 2023-01-31 |
P100009-S051 |
MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2023-01-27 |
P810002-S116 |
Masters Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Valved Graft with Hemashield graft technology (C |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2023-01-24 |
P010032-S189 |
Prodigy, Proclaim, and Proclaim XR Spinal Cord Stimulation (SCS) Systems |
Panel Track |
LGW |
— |
— |
| 2023-01-13 |
P190023-S002 |
Navitor Transcatheter Aortic Valve Implantation System; Navitor Transcatheter Aortic Heart Valve; FlexNav Delivery Syste |
Normal 180 Day Track |
NPT |
— |
— |
| 2023-01-10 |
P160054-S050 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2023-01-10 |
P060040-S089 |
HeartMate II Left Ventricular Assist System (LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2023-01-06 |
P100045-S064 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2022-12-16 |
P010032-S186 |
Eterna SCS IPG, Charger, Patient Controller Application, Clinician Programmer Application |
Normal 180 Day Track |
LGW |
— |
— |
| 2022-12-15 |
P100009-S050 |
MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2022-12-14 |
P190023-S011 |
Portico |
30-Day Notice |
NPT |
— |
— |
| 2022-12-14 |
P110016-S080 |
FlexAbility Ablation Catheter, Sensor Enabled |
Panel Track |
LPB |
Cardiac Ablation Percutaneous Catheter |
Unknown |
| 2022-12-14 |
P100029-S049 |
Trifecta |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-12-14 |
P040021-S051 |
Biocor/Epic |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-12-08 |
P110016-S081 |
FlexAbility Ablation Catheter / FlexAbility Ablation Catheter, Sensor Enabled (SE) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2022-12-07 |
P960030-S077 |
IsoFlex |
Real-Time Process |
NVN |
— |
— |
| 2022-12-07 |
P140033-S076 |
Assurity MRI, Endurity MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-12-06 |
P100029-S048 |
Trifecta Valve with Glide Technology |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-11-29 |
P100029-S047 |
Trifecta Valve with Glide Technology |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-11-20 |
P100009-S049 |
MitraClip G4 Clip Delivery System, MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2022-11-10 |
P060040-S088 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-11-09 |
P190023-S010 |
PorticoTM Transcatheter Aortic Valve Implantation System |
Real-Time Process |
NPT |
— |
— |
| 2022-10-28 |
P140009-S080 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-10-28 |
P010032-S194 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2022-10-17 |
P140009-S079 |
Deep Brain Stimulation (DBS) System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-10-17 |
P100009-S048 |
MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2022-10-14 |
P160054-S049 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2022-10-14 |
P060040-S087 |
HeartMate II Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2022-10-06 |
P150035-S002 |
Aveir |
30-Day Notice |
PNJ |
— |
— |
| 2022-09-30 |
P970013-S091 |
Microny family of Pacemakers |
Real-Time Process |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2022-09-30 |
P910023-S447 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+, Avant, Entrant, Gallant and |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-09-30 |
P880086-S325 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2022-09-30 |
P140033-S075 |
Assurity MRI, Endurity MRI family of Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-09-30 |
P030054-S401 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-09-30 |
P030035-S191 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Real-Time Process |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2022-09-15 |
P100045-S063 |
CardioMEMS HF System |
Normal 180 Day Track No User Fee |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2022-09-09 |
P910023-S448 |
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-09-09 |
P100009-S047 |
MitraClip Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2022-09-09 |
P030054-S402 |
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-09-09 |
P010032-S190 |
Spinal Cord Stimulation (SCS) |
30-Day Notice |
LGW |
— |
— |
| 2022-08-19 |
P150004-S057 |
Proclaim DRG Systems |
Real-Time Process |
PMP |
— |
— |
| 2022-08-19 |
P140009-S077 |
Infinity DBS Systems |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-08-19 |
P010032-S187 |
Proclaim SCS Systems |
Real-Time Process |
LGW |
— |
— |
| 2022-08-16 |
P100009-S046 |
MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2022-08-08 |
P100009-S045 |
MitraClip G4 Clip Delivery System |
Normal 180 Day Track No User Fee |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2022-08-01 |
P960030-S076 |
IsoFlex |
30-Day Notice |
NVN |
— |
— |
| 2022-08-01 |
P960013-S121 |
OptiSense, Tendril STS, Tendril SDX, Tendril ST |
30-Day Notice |
NVN |
— |
— |
| 2022-08-01 |
P950022-S143 |
Durata, Optisure |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-08-01 |
P190023-S009 |
Portico Transcatheter Aortic Valve Implantation System |
30-Day Notice |
NPT |
— |
— |
| 2022-08-01 |
P140033-S074 |
Tendril MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-08-01 |
P030054-S400 |
Quickflex µ, Quartet |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-07-28 |
P200049-S004 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2022-07-14 |
P910023-S446 |
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR and Entrant DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-07-14 |
P880086-S324 |
Assurity, Assurity+, Endurity, Endurity Core, Zenex and Zenus |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2022-07-14 |
P140033-S073 |
Assurity MRI, Endurity MRI, and Zenus MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-07-14 |
P030054-S399 |
Avant HF, Neutrino NxT HF, Gallant HF, and Entrant HF |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-07-14 |
P030035-S190 |
Allure Quadra |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2022-07-07 |
P190023-S008 |
Portico Transcatheter Aortic Heart Valve |
30-Day Notice |
NPT |
— |
— |
| 2022-06-30 |
P140009-S078 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-06-28 |
P010032-S188 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2022-06-23 |
P060040-S086 |
HeartMate II® Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2022-06-22 |
P910023-S445 |
Implantable Cardioverter Defibrillators |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-05-18 |
P910023-S444 |
Neutrino NxT VR, Gallant VR, Entrant VR, Neutrino NxT DR, Gallant DR, Entrant DR, Avant VR, Avant DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-05-17 |
P970013-S090 |
Microny family of Pacemakers |
Real-Time Process |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2022-05-17 |
P910023-S443 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-05-17 |
P880086-S323 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2022-05-17 |
P140033-S072 |
Assurity MRI, Endurity MRI family of Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-05-17 |
P030054-S398 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-05-17 |
P030035-S189 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Real-Time Process |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2022-05-04 |
P150035-S001 |
Aveir VR Leadless System: Aveir Leadless Pacemaker (Right Ventricular), Aveir Delivery System Catheter, Aveir Link M |
30-Day Notice |
PNJ |
— |
— |
| 2022-04-26 |
P040021-S050 |
Epic Plus Tissue Heart Valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-04-20 |
P190023-S007 |
Portico Transcatheter Aortic Heart Valve |
30-Day Notice |
NPT |
— |
— |
| 2022-04-14 |
P100029-S046 |
Trifecta and Trifecta Valve with Glide Technology (Trifecta GT) valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-04-14 |
P040021-S049 |
Epic, Epic Supra and Epic Plus Tissue Heart Valves, Biocor and Biocor Supra Tissue Heart Valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2022-04-12 |
P100045-S059 |
CardioMEMS HF System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2022-04-11 |
P160054-S047 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-04-11 |
P100045-S062 |
CardioMEMS PA Sensor and Delivery System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2022-04-11 |
P060040-S085 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-03-31 |
P150035 |
Aveir VR Leadless System |
Original |
PNJ |
— |
— |
| 2022-03-31 |
P100045-S061 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2022-03-24 |
P160054-S039 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track No User Fee |
DSQ |
— |
— |
| 2022-03-24 |
P150004-S056 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2022-03-24 |
P140009-S076 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-03-24 |
P010032-S185 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2022-03-07 |
P190023-S005 |
Portico |
30-Day Notice |
NPT |
— |
— |
| 2022-03-04 |
P190023-S006 |
Portico Transcatheter Aortic Heart Valve |
30-Day Notice |
NPT |
— |
— |
| 2022-03-04 |
P100045-S060 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2022-02-18 |
P100045-S056 |
CardioMEMs HF System |
Panel Track |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2022-02-17 |
P150004-S055 |
Dorsal Root Ganglion (DRG) System |
30-Day Notice |
PMP |
— |
— |
| 2022-02-17 |
P140009-S075 |
Infinity Deep Brain Stimulation (DBS) System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2022-02-17 |
P010032-S184 |
Spinal Cord Stimulation (SCS) System |
30-Day Notice |
LGW |
— |
— |
| 2022-02-16 |
P160054-S042 |
HeartMate 3 Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2022-01-28 |
P160054-S045 |
HeartMate 3 Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2022-01-28 |
P060040-S083 |
HeartMate II Left Ventricular Assist System |
Real-Time Process |
DSQ |
— |
— |
| 2022-01-13 |
P910023-S442 |
Avant VR; Neutrino NxT VR; Gallant VR; Neutrino NxT VR; Entrant VR; Avant DR; Neutrino NxT DR; Gallant DR; Neutrino NxT |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-01-13 |
P120021-S022 |
Amplatzer PFO Occluder |
Real-Time Process |
MLV |
— |
— |
| 2022-01-13 |
P040040-S045 |
Amplatzer Muscular VSD Occluder |
Real-Time Process |
MLV |
— |
— |
| 2022-01-13 |
P030054-S397 |
Avant HF; Neutrino NxT HF; Gallant HF; Neutrino NxT HF; Entrant HF; |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-01-13 |
P020024-S066 |
Amplatzer Duct Occluder, Amplatzer Duct Occluder II |
Real-Time Process |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2022-01-13 |
P000039-S076 |
Amplatzer Septal Occluder and Amplatzer Cribriform Occluder |
Real-Time Process |
MLV |
— |
— |
| 2022-01-12 |
P160054-S044 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Special (Immediate Track) |
DSQ |
— |
— |
| 2022-01-12 |
P060040-S082 |
HeartMate II Left Ventricular Assist System (LVAS) |
Special (Immediate Track) |
DSQ |
— |
— |
| 2022-01-07 |
P970013-S089 |
Microny family of Pacemakers |
Real-Time Process |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2022-01-07 |
P910023-S441 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2022-01-07 |
P880086-S322 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers. |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2022-01-07 |
P160054-S043 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2022-01-07 |
P140033-S071 |
Assurity MRI, Endurity MRI family of Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2022-01-07 |
P030054-S396 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2022-01-07 |
P030035-S188 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Real-Time Process |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2021-12-30 |
P150004-S053 |
Dorsal Root Ganglion (DRG) System |
Normal 180 Day Track No User Fee |
PMP |
— |
— |
| 2021-12-30 |
P140009-S073 |
Deep Brain Stimulation (DBS) System |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-12-30 |
P010032-S180 |
Spinal Cord Stimulation (SCS) System |
Normal 180 Day Track No User Fee |
LGW |
— |
— |
| 2021-12-22 |
P120021-S023 |
AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder |
Normal 180 Day Track No User Fee |
MLV |
— |
— |
| 2021-12-20 |
P160054-S041 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-12-16 |
P190023-S004 |
Portico Transcatheter Heart Valve |
30-Day Notice |
NPT |
— |
— |
| 2021-12-16 |
P100029-S045 |
Trifecta Valve with Glide Technology (Trifecta GT) |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2021-12-16 |
P040021-S048 |
Biocor, Biocor Supra, Epic, Epic Supra, Epic Plus, Epic Plus Supra |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2021-12-13 |
P190023-S003 |
Portico TAVI System |
135 Review Track For 30-Day Notice |
NPT |
— |
— |
| 2021-12-09 |
P810002-S115 |
Masters HP Valved Graft with Gelweave Valsalva Technology (VAVGJ) |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2021-12-09 |
P200049-S002 |
Amplatzer Amulet LAA Occluder |
Normal 180 Day Track No User Fee |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-12-08 |
P960013-S118 |
Tendril STS Pacing Leads |
Normal 180 Day Track |
NVN |
— |
— |
| 2021-12-01 |
P950022-S142 |
Optisure |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-11-24 |
P160054-S040 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-11-24 |
P060040-S081 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-11-23 |
P100045-S052 |
CardioMEMS HF System |
Normal 180 Day Track No User Fee |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-11-17 |
P010032-S176 |
Proclaim SCS Neurostimulation System |
Normal 180 Day Track |
LGW |
— |
— |
| 2021-11-16 |
P200049-S003 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-11-16 |
P150004-S054 |
Proclaim DRG IPG |
Real-Time Process |
PMP |
— |
— |
| 2021-11-16 |
P140009-S074 |
Infinity DBS IPG |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-11-16 |
P010032-S183 |
Proclaim SCS IPG |
Real-Time Process |
LGW |
— |
— |
| 2021-11-12 |
P190023-S001 |
Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System |
Normal 180 Day Track No User Fee |
NPT |
— |
— |
| 2021-11-04 |
P010032-S182 |
Eon Mini IPG, 16-Channel Rechargeable; Prodigy MRI IPG; Protégé IPG; Protégé MRI IPG; Eon Patient Programmer; Patient P |
30-Day Notice |
LGW |
— |
— |
| 2021-11-03 |
P010032-S181 |
Genesis Neurostimulation System |
30-Day Notice |
LGW |
— |
— |
| 2021-10-22 |
P100009-S044 |
MitraClip NTR/XTR Clip Delivery System; MitraClip G4 Clip Delivery System (NT, NTW, XT, XTW) |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2021-10-20 |
P810002-S114 |
BILEAFLET-CENTER OPENING CARDIAC VALVE |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2021-10-14 |
P110016-S079 |
Ampere Generator |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-10-07 |
P160054-S038 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-10-07 |
P060040-S080 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-10-05 |
P100045-S057 |
CardioMEMS HF System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-09-27 |
P150004-S049 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
Real-Time Process |
PMP |
— |
— |
| 2021-09-27 |
P140009-S071 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-09-27 |
P120021-S020 |
Amplatzer Talisman PFO Occluder |
Normal 180 Day Track |
MLV |
— |
— |
| 2021-09-27 |
P010032-S178 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Real-Time Process |
LGW |
— |
— |
| 2021-09-22 |
P200049-S001 |
Amplatzer Amulet Left Atrial Appendage Occluder |
30-Day Notice |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-09-22 |
P110016-S078 |
FlexAbility Ablation Catheter, FlexAbility Ablation Catheter Sensor Enabled |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-09-22 |
P000039-S075 |
Amplatzer Septal Occluder |
30-Day Notice |
MLV |
— |
— |
| 2021-09-21 |
P100045-S049 |
CardioMEMS HF System |
Normal 180 Day Track |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-09-17 |
P190023 |
Portico Transcatheter Aortic Valve Implantation System |
Original |
NPT |
— |
— |
| 2021-09-17 |
P040021-S047 |
Epic, Epic Supra and Epic Plus Tissue Heart Valves |
Real-Time Process |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2021-09-16 |
P100045-S058 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-09-15 |
P970013-S085 |
Microny family of Pacemakers |
Normal 180 Day Track |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2021-09-15 |
P910023-S439 |
Ellipse VR DR, Fortify Assura VR DR |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-15 |
P910023-S435 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-15 |
P880086-S321 |
Endurity Core, Endurity, Zenex, Zenus |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2021-09-15 |
P880086-S317 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2021-09-15 |
P140033-S070 |
Zenex MRI, Zenus MRI |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-15 |
P140033-S065 |
Assurity MRI and Endurity MRI family of Pacemakers |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-09-15 |
P030054-S394 |
Quadra Assura MP, Quadra Assura, Unify Assura |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-09-15 |
P030054-S389 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra, Assura, Epic+/HF/HF+/II HF/II+ |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-09-15 |
P030035-S184 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2021-09-01 |
P910023-S440 |
Avant VR, Neutrino NxT VR, Gallant VR, Entrant VR, Avant DR, Neutrino NxT DR, Gallant DR, Entrant DR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-09-01 |
P030054-S395 |
Avant HF, Neutrino NxT HF, Gallant HF, Entrant HF, |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-08-19 |
P810002-S113 |
Masters Mechanical Heart Valve |
Special (Immediate Track) |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2021-08-14 |
P200049 |
Amplatzer Amulet Left Atrial Appendage Occluder |
Original |
NGV |
System, Appendage Closure, Left Atrial |
Unknown |
| 2021-08-13 |
P140033-S068 |
Assurity MRI, Endurity MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-08-10 |
P100045-S054 |
CardioMEMS HF System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-08-10 |
P100045-S053 |
CardioMEMS HF System |
Normal 180 Day Track |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-08-09 |
P960013-S120 |
Tendril STS, Tendril ST, Optisense |
30-Day Notice |
NVN |
— |
— |
| 2021-08-09 |
P950022-S141 |
Durata, Optisure |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-08-05 |
P150004-S051 |
Axium Neurostimulator System |
Normal 180 Day Track No User Fee |
PMP |
— |
— |
| 2021-08-01 |
P100009-S043 |
MitraClip NTR/XTR System, MitraClip G4System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2021-07-29 |
P950022-S140 |
Durata, Optisure |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-07-28 |
P150004-S050 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2021-07-28 |
P140009-S072 |
Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-07-28 |
P010032-S179 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2021-07-27 |
P120021-S021 |
Amplatzer Patent Foramen Ovale (PFO) Occluder |
30-Day Notice |
MLV |
— |
— |
| 2021-07-27 |
P040040-S044 |
Amplatzer Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2021-07-27 |
P020024-S065 |
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2021-07-27 |
P000039-S074 |
Amplatzer Septal Occluder, Amplatzer Multi-Fenestrated Septal Occluder |
30-Day Notice |
MLV |
— |
— |
| 2021-07-26 |
P140009-S067 |
Deep Brain Stimulation (DBS) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-07-26 |
P010032-S172 |
Spinal Cord Stimulation (SCS) |
Real-Time Process |
LGW |
— |
— |
| 2021-07-15 |
P150004-S048 |
St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim DRG Implant |
Special (Immediate Track) |
PMP |
— |
— |
| 2021-07-15 |
P140009-S070 |
St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, St. Jude Medical In |
Special (Immediate Track) |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-07-15 |
P010032-S177 |
St. Jude Medical Clinician Programmer Application, St. Jude Medical Patient Controller Application, Proclaim XR 5 Implan |
Special (Immediate Track) |
LGW |
— |
— |
| 2021-07-07 |
P970013-S088 |
Microny |
30-Day Notice |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2021-07-07 |
P960030-S075 |
IsoFlex Optim |
30-Day Notice |
NVN |
— |
— |
| 2021-07-07 |
P960013-S119 |
Tendril SDX Lead, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) |
30-Day Notice |
NVN |
— |
— |
| 2021-07-07 |
P950022-S139 |
Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-07-07 |
P910023-S438 |
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Entrant, Gallant, Ellipse (MR Conditional) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-07-07 |
P880086-S320 |
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2021-07-07 |
P140033-S069 |
Assurity MRI, Endurity MRI, Tendril MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-07-07 |
P030054-S393 |
Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-07-07 |
P030035-S187 |
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MR Conditional) |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2021-07-02 |
P150004-S045 |
Dorsal Root Ganglion (DRG) Stimulation System |
135 Review Track For 30-Day Notice |
PMP |
— |
— |
| 2021-07-02 |
P010032-S173 |
Spinal Cord Stimulation (SCS) System |
135 Review Track For 30-Day Notice |
LGW |
— |
— |
| 2021-07-01 |
P100045-S055 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-06-28 |
P970013-S087 |
Microny family of Pacemakers |
Real-Time Process |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2021-06-28 |
P910023-S437 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-06-28 |
P880086-S319 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2021-06-28 |
P140033-S067 |
Assurity MRI, Endurity MRI family of Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-06-28 |
P030054-S392 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-06-28 |
P030035-S186 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Real-Time Process |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2021-06-25 |
P110016-S077 |
FlexAbility Ablation Catheter (FlexAbility) and FlexAbility Ablation Catheter, Sensor Enabled (FlexAbility SE) |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-06-22 |
P150004-S044 |
NextGen DRG Lead Kit and Accessories |
Normal 180 Day Track |
PMP |
— |
— |
| 2021-06-10 |
P160054-S037 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-06-08 |
P150004-S047 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2021-06-08 |
P140009-S069 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-06-08 |
P010032-S175 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2021-06-03 |
P100009-S042 |
MitraClip NTR/XTR Delivery System |
Real-Time Process |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2021-05-28 |
P040021-S046 |
Epic and Epic Supra Tissue Heart Valves |
Special (Immediate Track) |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2021-05-18 |
P110016-S076 |
FlexAbility and FlexAbility SE Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-05-04 |
P110016-S075 |
Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-04-28 |
P160054-S036 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2021-04-23 |
P150004-S046 |
Dorsal Root Ganglion (DRG) System |
30-Day Notice |
PMP |
— |
— |
| 2021-04-23 |
P140009-S068 |
Deep Brain Stimulation (DBS) System |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-04-23 |
P010032-S174 |
Spinal Cord Stimulation (SCS) System |
30-Day Notice |
LGW |
— |
— |
| 2021-04-22 |
P100045-S051 |
CardioMEMS I3 Patient Electronics System (PES) |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-04-09 |
P970013-S086 |
Microny |
30-Day Notice |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2021-04-09 |
P960030-S074 |
IsoFlex Optim |
30-Day Notice |
NVN |
— |
— |
| 2021-04-09 |
P960013-S117 |
Tendril ST Lead, OptiSense, Tendril STS Lead and Tendril STS Lead (MR Conditional) |
30-Day Notice |
NVN |
— |
— |
| 2021-04-09 |
P950022-S138 |
Durata, Durata (MR Conditional), Optisure and Optisure (MR Conditional) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-09 |
P910023-S436 |
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse and Ellipse (MR Conditional) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2021-04-09 |
P880086-S318 |
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL and Verity ADx XL |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2021-04-09 |
P140033-S066 |
Assurity MRI, Endurity MRI and Tendril MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2021-04-09 |
P030054-S391 |
Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass |
30-Day Notice |
— |
— |
— |
| 2021-04-09 |
P030035-S185 |
Allure, Allure Quadra, Quadra Allure MP and Quadra Allure (MRI Conditional) |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2021-04-06 |
P100045-S050 |
Cardiomems HF System |
Normal 180 Day Track No User Fee |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-03-24 |
P110016-S074 |
Therapy Cool Path Duo and Therapy Cool Flex |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-03-23 |
P160054-S035 |
HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2021-03-21 |
P160054-S034 |
HeartMate 3 Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-03-21 |
P060040-S079 |
HeartMate II Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2021-03-18 |
P960030-S073 |
IsoFlex |
30-Day Notice |
NVN |
— |
— |
| 2021-03-18 |
P030054-S390 |
QuickFlex µ and Quartet |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2021-03-17 |
P810002-S110 |
Medical Mechanical Heart Valve |
135 Review Track For 30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2021-03-12 |
P110016-S073 |
Therapy Cool Path Duo, Safire BLU Duo, Cool Path, Duo, Safire Duo, Therapy Cool Path Duo SP, Safire, BLU Duo SP and Ther |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2021-03-12 |
P100045-S047 |
CardioMEMS HF System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-03-09 |
P100045-S048 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2021-03-09 |
P100009-S039 |
MitraClip NT Clip Delivery System, MitraClip XT Clip Delivery System, and MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2021-03-05 |
P150004-S043 |
Proclaim DRG IPG |
Normal 180 Day Track |
PMP |
— |
— |
| 2021-03-05 |
P140009-S066 |
Deep Brain Stimulation Multilead Trial Cable (DBS MLTC) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-03-05 |
P140009-S064 |
Infinity family of DBS IPGs |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-03-05 |
P010032-S168 |
Proclaim family of SCS IPGs |
Normal 180 Day Track |
LGW |
— |
— |
| 2021-02-24 |
P140009-S065 |
Deep Brain Stimulation (DBS) System |
135 Review Track For 30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-02-24 |
P010032-S169 |
Spinal Cord Stimulation (SCS) System |
135 Review Track For 30-Day Notice |
LGW |
— |
— |
| 2021-02-22 |
P140009-S053 |
Internal Leads Extensions and 8 Chanel Adapters |
Normal 180 Day Track No User Fee |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-02-22 |
P100009-S038 |
MitraClip Clip System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2021-02-22 |
P010032-S157 |
Paddle Leads |
Normal 180 Day Track No User Fee |
LGW |
— |
— |
| 2021-02-03 |
P010032-S170 |
Genesis Neurostimulation System |
30-Day Notice |
LGW |
— |
— |
| 2021-01-21 |
P150004-S040 |
Axium Neurostimulator System |
Normal 180 Day Track No User Fee |
PMP |
— |
— |
| 2021-01-19 |
P150004-S041 |
Proclaim SCS Neurostimulator System |
Normal 180 Day Track |
PMP |
— |
— |
| 2021-01-19 |
P140009-S062 |
Proclaim SCS Neurostimulation System |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2021-01-19 |
P010032-S166 |
Proclaim SCS Neurostimulation System |
Normal 180 Day Track |
LGW |
— |
— |
| 2021-01-07 |
P160054-S033 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2021-01-06 |
P110016-S072 |
FlexAbility Ablation Catheter, Sensor Enabled |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-12-22 |
P100045-S046 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2020-12-17 |
P160054-S031 |
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-12-16 |
P960013-S114 |
Tendril STS |
Normal 180 Day Track |
NVN |
— |
— |
| 2020-12-16 |
P140033-S060 |
Assurity MRI and Endurity MRI |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-15 |
P960030-S072 |
IsoFlex Optim, Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) |
30-Day Notice |
NVN |
— |
— |
| 2020-12-15 |
P960013-S116 |
Tendril DX Endocardial Pacing Leads |
30-Day Notice |
NVN |
— |
— |
| 2020-12-15 |
P950022-S137 |
Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-15 |
P910023-S434 |
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional), Avant VR, Avant D |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-12-15 |
P880086-S316 |
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-12-15 |
P140033-S064 |
Assurity MRI, Endurity MRI, Tendril MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-12-15 |
P030054-S388 |
Promote+, Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-12-15 |
P030035-S183 |
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2020-12-10 |
P040021-S045 |
Biocor, Biocor Supra, Epic and Epic Supra Tissue Heart Valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-11-20 |
P140033-S062 |
Tendril MRI |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-11-20 |
P030054-S387 |
Cardiac Resynchronization Therapy (CRT) |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-11-15 |
P010032-S165 |
Protege/Prodigy/Proclaim XR family of SCS IPGs, SCS EPG and SCS Percutaneous Permanent and Trial leads |
Normal 180 Day Track |
LGW |
— |
— |
| 2020-11-02 |
P110016-S070 |
Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path Duo SP, Safire BLU Duo SP and Therap |
Normal 180 Day Track |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-10-29 |
P880086-S314 |
Assurity, Assurity+, and Endurity |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-10-29 |
P140033-S061 |
Assurity MRI and Endurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-28 |
P910023-S430 |
Fortify, Fortify Assura, and Ellipse |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-28 |
P030054-S382 |
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-10-27 |
P060040-S078 |
HeartMate II Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2020-10-26 |
P970013-S084 |
Microny |
30-Day Notice |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2020-10-26 |
P960030-S071 |
IsoFlex Optim |
30-Day Notice |
NVN |
— |
— |
| 2020-10-26 |
P960013-S115 |
Tendril ST Lead, OptiSense, Tendril STS Lead, Tendril STS Lead (MR Conditional) |
30-Day Notice |
NVN |
— |
— |
| 2020-10-26 |
P950022-S136 |
Durata, Durata (MR Conditional), Optisure, Optisure (MR Conditional) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-26 |
P910023-S433 |
Current+, Fortify, Fortify Assura, Fortify Assura (MR Conditional), Ellipse, Ellipse (MR Conditional) |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-26 |
P880086-S315 |
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-10-26 |
P140033-S063 |
Assurity MRI, Endurity MRI, Tendril MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-10-26 |
P030054-S386 |
Promote+, Unity, Unity Quadra, Unity Assura, Quadra Assura, Quadra Assura (MR Conditional), Quadra Assura MP, Quadra Ass |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-10-26 |
P030035-S182 |
Anthem, Allure, Allure Quadra, Quadra Allure MP, Quadra Allure (MRI Conditional) |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2020-10-20 |
P160054-S032 |
HeartMate 3 Left Ventricular Assist System (HM3 LVAS) |
Real-Time Process |
DSQ |
— |
— |
| 2020-10-16 |
P960030-S070 |
Isoflex |
Real-Time Process |
NVN |
— |
— |
| 2020-10-16 |
P950022-S135 |
Durata, Optisure |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-10-16 |
P110016-S071 |
Therapy Cool Flex Ablation Catheter, Therapy Cool Path Duo Ablation Catheter, Safire Duo Ablation Catheter, MediGuide En |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-10-16 |
P030054-S384 |
Quickflex µ, Quartet |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-10-14 |
P100029-S043 |
Trifecta and Trifecta Valve with Glide Technology |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-10-14 |
P040021-S044 |
Biocor, Biocor Supra, Epic, Epic Supra |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-10-06 |
P120021-S016 |
AMPLATZER PFO Occluder |
135 Review Track For 30-Day Notice |
MLV |
— |
— |
| 2020-10-06 |
P040040-S041 |
AMPLATZER Muscular VSD Occluder |
135 Review Track For 30-Day Notice |
MLV |
— |
— |
| 2020-10-06 |
P020024-S061 |
AMPLATZER Duct Occluder |
135 Review Track For 30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2020-10-06 |
P000039-S071 |
AMPLATZER Septal Occluder and AMPLATZER Multi-Fenestrated Septal (Cribriform) Occluder |
135 Review Track For 30-Day Notice |
MLV |
— |
— |
| 2020-09-23 |
P910023-S432 |
Avant VR ICD, Avant DR ICD, Neutrino NxT VR ICD, Neutrino NxT DR ICD, Gallant VR ICD, Gallant DR ICD, Entrant VR ICD and |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-09-23 |
P030054-S385 |
Avant HF CRT-D, Neutrino NxT HF CRT-D, Gallant HF CRT-D, and Entrant HF CRT-D |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-09-22 |
P910023-S428 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify, Assura, Epic/Epic+, Atlas/II/+, Avant, Gallant, Entrant, Ne |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-09-22 |
P030054-S380 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/ II+ |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-09-15 |
P910023-S429 |
Avanta, Neutrino NXT, Gallant, Entrant VR ICD and Avant, Neutrino, Gallant and Entrant DR ICD |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-09-15 |
P030054-S381 |
Avant HF, Neutrino NxT HF, Gallant HF and Entrant HF CRT-D |
Real-Time Process |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-08-18 |
P150004-S042 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
Real-Time Process |
PMP |
— |
— |
| 2020-08-18 |
P140009-S063 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-08-18 |
P010032-S167 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
Real-Time Process |
LGW |
— |
— |
| 2020-08-14 |
P100045-S045 |
CardioMEMS HS System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2020-08-12 |
P140009-S061 |
Infinity Deep Brain Stimulation (DBS) System |
Special (Immediate Track) |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-08-06 |
P910023-S431 |
Ellipse, Fortify, Fortify Assura, Quadra Assura MP, Avant, Gallant, Entrant, Neutrino NxT |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-08-06 |
P030054-S383 |
Quadra Assura, Unify, Unify Assura, Unify Quadra, Avant, Gallant, Entrant, Neutrino NxT |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-08-04 |
P100045-S043 |
CardioMEMS HF System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2020-07-28 |
P100045-S044 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2020-07-10 |
P160054-S029 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-07-09 |
P020024-S062 |
Amplatzer Piccolo Occluder |
Normal 180 Day Track No User Fee |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2020-07-01 |
P150004-S037 |
Proclaim DRG IPG |
Real-Time Process |
PMP |
— |
— |
| 2020-07-01 |
P140009-S058 |
Infinity DBS IPG |
Real-Time Process |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-07-01 |
P010032-S162 |
Proclaim family of SCS IPG |
Real-Time Process |
LGW |
— |
— |
| 2020-06-30 |
P970013-S082 |
Microny family of Pacemakers |
Normal 180 Day Track |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2020-06-30 |
P950022-S134 |
Durata And Optisure HV Passive Steroid Eluting Cardiac Leads |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-30 |
P910023-S423 |
Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs |
Normal 180 Day Track |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-30 |
P880086-S308 |
Assurity, Assurity+, Endurity, Accent family of Pacemakers |
Normal 180 Day Track |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-06-30 |
P140033-S050 |
Assurity MRI, Endurity MRI family of Pacemakers |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-30 |
P030054-S374 |
Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+ |
Normal 180 Day Track |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-06-30 |
P030035-S178 |
Anthem, Allure/RF, Allure Quadra/RF family of CRT-Ps |
Normal 180 Day Track |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2020-06-26 |
P160054-S025 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-06-26 |
P140033-S054 |
Accent MRI Pacemaker |
Normal 180 Day Track |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-26 |
P060040-S076 |
HeartMate II Left Ventricular Assist System (LVAS) |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-06-18 |
P960030-S069 |
Isoflex |
30-Day Notice |
NVN |
— |
— |
| 2020-06-18 |
P960013-S113 |
Tendril SDX, OptiSense, Tendril STS, Tendril ST |
30-Day Notice |
NVN |
— |
— |
| 2020-06-18 |
P950022-S133 |
Durata and Optisure High Voltage Leads |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-18 |
P140033-S059 |
Tendril MRl |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-06-18 |
P030054-S379 |
Quickflex µ, Quartet |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-06-17 |
P960013-S112 |
OptiSense Steroid Eluting Cardiac Lead |
30-Day Notice |
NVN |
— |
— |
| 2020-06-13 |
P160054-S030 |
HeartMate 3 (HM3) Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2020-06-05 |
P150004-S033 |
Proclaim DRG IPG |
Normal 180 Day Track |
PMP |
— |
— |
| 2020-06-05 |
P140009-S052 |
Infinity Family of DBS IPGs |
Normal 180 Day Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-06-05 |
P010032-S156 |
Proclaim family of SCS IPGs |
Normal 180 Day Track |
LGW |
— |
— |
| 2020-06-04 |
P950022-S132 |
Durata HV Leads |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-06-04 |
P150004-S039 |
Dorsal Root Ganglion (DRG) Stimulation |
30-Day Notice |
PMP |
— |
— |
| 2020-06-04 |
P140009-S060 |
Deep Brain Stimulation (DBS) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-06-04 |
P120021-S018 |
Amplatzer PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-06-04 |
P110016-S069 |
FlexAbility and FlexAbility SE Ablation Catheter, FlexAbility Cables Sensor Enabled |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-06-04 |
P040040-S043 |
Amplatzer Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-06-04 |
P020024-S064 |
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2020-06-04 |
P010032-S164 |
Spinal Cord Stimulation (SCS) |
30-Day Notice |
LGW |
— |
— |
| 2020-06-04 |
P000039-S073 |
Amplatzer Septal Occluder, Amplatzer Multi-Fenestrated Septal Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-05-30 |
P150004-S038 |
Dorsal Root Ganglion Stimulator for Pain Relief |
30-Day Notice |
PMP |
— |
— |
| 2020-05-30 |
P140009-S059 |
Deep Brain Stimulation Therapy |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-05-30 |
P010032-S163 |
Totally Implanted Spinal Cord Stimulator for Pain Relief |
30-Day Notice |
LGW |
— |
— |
| 2020-05-26 |
P810002-S112 |
SJM Masters Valved Graft with Hemashield graft technology |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2020-05-23 |
P120021-S017 |
AMPLATZER PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-05-23 |
P040040-S042 |
AMPLATZER Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-05-23 |
P020024-S063 |
AMPLATZER Duct Occluder Family (ADO, ADOII, Piccolo) |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2020-05-23 |
P000039-S072 |
AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-05-22 |
P140033-S057 |
Tendril MRI |
Normal 180 Day Track No User Fee |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-05-21 |
P910023-S427 |
Fortify, Fortify Assura, and Ellipse |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-05-21 |
P880086-S313 |
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-05-21 |
P140033-S058 |
Assurity MRI and Endurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-05-21 |
P030054-S378 |
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, and Quartet CRT Leads |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-05-21 |
P030035-S181 |
Allure, Allure Quadra, and Quadra Allure MP |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2020-05-18 |
P810002-S108 |
SJM Masters HP Valved Graft |
Normal 180 Day Track |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2020-05-17 |
P950022-S112 |
Durata and Optisure High Voltage Lead |
Real-Time Process |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-05-15 |
P950022-S131 |
Optisure High Voltage Leads |
Normal 180 Day Track No User Fee |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-05-13 |
P880086-S306 |
Assurity, Endurity Core Family of Pacemakers |
Real-Time Process |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-05-13 |
P140033-S048 |
Assurity MRI, Endurity MRI family of Pacemakers |
Real-Time Process |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-05-12 |
P810002-S111 |
Mechanical Heart Valve |
30-Day Notice |
LWQ |
Heart-Valve, Mechanical |
Unknown |
| 2020-05-06 |
P150004-S036 |
Dorsal Root Ganglion (DRG) Implantable Pulse Generator (IPG) |
30-Day Notice |
PMP |
— |
— |
| 2020-05-06 |
P150004-S035 |
Proclaim DRG IPG |
30-Day Notice |
PMP |
— |
— |
| 2020-05-06 |
P140009-S057 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-05-06 |
P140009-S056 |
Infinity DBS IPGs |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-05-06 |
P010032-S161 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2020-05-06 |
P010032-S160 |
Proclaim family of SCS IPGs |
30-Day Notice |
LGW |
— |
— |
| 2020-04-25 |
P040021-S043 |
Biocor, Biocor Supra, Epic, and Epic Supra Valves |
30-Day Notice |
LWR |
Heart-Valve, Non-Allograft Tissue |
Unknown |
| 2020-04-24 |
P110016-S067 |
Therapy Cool Path Duo Ablation Catheter, Therapy Cool Flex Ablation Catheter, Cool Path Duo, MediGuide Enabled, and Safi |
Real-Time Process |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-04-16 |
P160054-S028 |
HeartMate 3 (HM3) Left Ventricular Assist System |
30-Day Notice |
DSQ |
— |
— |
| 2020-04-16 |
P120021-S015 |
Amplatzer PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-04-16 |
P110016-S068 |
FlexAbility and FlexAbility SE Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-04-16 |
P040040-S040 |
Amplatzer Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-04-16 |
P020024-S060 |
Amplatzer Duct Occluder, Amplatzer Duct Occluder II, and Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2020-04-16 |
P000039-S070 |
Amplatzer Septal Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-04-15 |
P120021-S014 |
Amplatzer PFO Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-04-15 |
P040040-S039 |
Amplatzer Muscular VSD Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-04-15 |
P020024-S059 |
Amplatzer Duct Occluder/Amplatzer Duct Occluder II/Amplatzer Piccolo Occluder |
30-Day Notice |
MAE |
Occluder, Patent Ductus, Arteriosus |
Unknown |
| 2020-04-15 |
P000039-S069 |
Amplatzer Septal Occluder/Amplatzer Cribriform Occluder |
30-Day Notice |
MLV |
— |
— |
| 2020-04-14 |
P100045-S042 |
CardioMEMS HF System |
30-Day Notice |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2020-04-09 |
P160054-S026 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2020-04-09 |
P060040-S077 |
HeartMate II Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2020-03-30 |
P160054-S027 |
HeartMate 3 Left Ventricular Assist System (LVAS) |
30-Day Notice |
DSQ |
— |
— |
| 2020-03-26 |
P960030-S068 |
Isoflex |
30-Day Notice |
NVN |
— |
— |
| 2020-03-26 |
P960013-S111 |
Tendril SDX, OptiSense, Tendril STS, and Tendril ST |
30-Day Notice |
NVN |
— |
— |
| 2020-03-26 |
P950022-S130 |
Durata, Optisure |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-03-26 |
P140033-S056 |
Tendril MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-03-26 |
P030054-S377 |
Quickflex, Quartet |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-03-13 |
P910023-S426 |
Ellipse DR and Ellipse VR |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-03-04 |
P140009-S055 |
Infinity Deep Brain Stimulation (DBS) Implantable Pulse Generator (IPG) |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-03-04 |
P110016-S066 |
Therapy Cool Path Duo Ablation Catheter |
30-Day Notice |
OAD |
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter |
Unknown |
| 2020-03-04 |
P010032-S159 |
Spinal Cord Stimulation (SCS) Implantable Pulse Generator (IPG) |
30-Day Notice |
LGW |
— |
— |
| 2020-02-28 |
P970013-S083 |
Microny |
30-Day Notice |
LWO |
Pulse-Generator, Single Chamber, Sensor Driven, Implantable |
Unknown |
| 2020-02-28 |
P910023-S425 |
Fortify, Fortify Assura, and Ellipse |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-02-28 |
P880086-S312 |
Victory, Zephyr, Accent, Assurity, Assurity+, Endurity, Identity XL, Identity ADx XL, Verity ADx XL, Sustain XL DC, Sust |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-02-28 |
P140033-S055 |
Assurity MRI, Endurity MRI, MRI Activator, and Tendril MRI |
30-Day Notice |
— |
— |
— |
| 2020-02-28 |
P030054-S376 |
Unify, Unify Quadra, Unify Assura, Quadra Assura, Quadra Assura MP, QuickFlex µ, Quartet, Quartet CRT Leads, and Quartet |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-02-28 |
P030035-S180 |
Allure, Allure Quadra, and Quadra Allure MP |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2020-02-26 |
P100009-S037 |
MitraClip NTR Clip Delivery System, MitraClip XTR Clip Delivery System, and MitraClip G4 Clip Delivery System |
30-Day Notice |
NKM |
Mitral Valve Repair Devices |
Unknown |
| 2020-02-24 |
P950022-S129 |
Durata and Optisure |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-02-05 |
P100045-S041 |
CardioMEMS HF System |
Real-Time Process |
MOM |
System, Hemodynamic, Implantable |
Unknown |
| 2020-01-27 |
P160054-S021 |
HeartMate 3 Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-01-27 |
P060040-S073 |
HeartMate II Left Ventricular Assist System |
Normal 180 Day Track |
DSQ |
— |
— |
| 2020-01-10 |
P150004-S034 |
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG. |
30-Day Notice |
PMP |
— |
— |
| 2020-01-10 |
P140009-S054 |
Proclaim SCS IPG, Infinity DBS IPG, and Proclaim DRG IPG |
30-Day Notice |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |
| 2020-01-10 |
P010032-S158 |
Proclaim SCS IPG, Infinity DBS IPG, Proclaim DRG IPG |
30-Day Notice |
LGW |
— |
— |
| 2020-01-06 |
P910023-S424 |
Current+, Fortify, Fortify Assura, Ellipse |
30-Day Notice |
LWS |
Implantable Cardioverter Defibrillator (Non-Crt) |
Unknown |
| 2020-01-06 |
P880086-S311 |
Endurity, Endurity Core, and Assurity pacemakers |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-01-06 |
P880086-S310 |
Endurity, Assurity, and Accent |
30-Day Notice |
DXY |
Implantable Pacemaker Pulse-Generator |
Cardiovascular |
| 2020-01-06 |
P140033-S053 |
Endurity MRI, and Assurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-01-06 |
P140033-S052 |
Assurity MRI, Endurity MRI |
30-Day Notice |
LWP |
Implantable Pulse Generator, Pacemaker (Non-Crt) |
Unknown |
| 2020-01-06 |
P030054-S375 |
Promote+, Unify, Unify Quandra, Unify Assura, Quadra Assura, Quadra Assura MP |
30-Day Notice |
NIK |
Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) |
Unknown |
| 2020-01-06 |
P030035-S179 |
Allure, Allure Quadra, Quadra Allure, Anthem, and Quadra Allure MP |
30-Day Notice |
NKE |
Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P) |
Unknown |
| 2020-01-02 |
P140009-S039 |
St. Jude Medical Infinity DBS Implantable Pulse Generator |
Panel Track |
MHY |
Stimulator, Electrical, Implanted, For Parkinsonian Tremor |
Unknown |