Chrysalis Intelligence · Sponsors · Medtronic Cardiac Rhythm Disease Management

Medtronic Cardiac Rhythm Disease Management

0 510(k) clearances · 634 PMAs

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Product codes worked

Code Device name Class Specialty Clearances Most recent
Class III

PMA approvals (634)

Total PMA records
634
Originals + supplements
Distinct product codes
5
First decision
2020-01-07
Most recent
2026-09-25
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-09-25 P980016-S965 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-09-25 P010031-S932 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-08-05 P030036-S161 SelectSecure Lead 3830 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-07-31 P980016-S963 Evera MRI DF-1 ICD (DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1); Evera MRI ICD (DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4); Evera S DR 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-07-31 P980016-S962 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-07-31 P980016-S961 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-07-31 P010031-S930 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4) Brava Quad 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-07-31 P010031-S929 Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome MR 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-07-31 P010031-S928 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4);Brava Quad 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-07-22 P980016-S960 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-07-22 P010031-S927 Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRTD DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D1, DTBC1D4; Brava Quad CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-07-16 P980016-S959 Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-07-16 P010031-S926 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-06-25 P980016-S955 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DDBC3D4 Evera S VR ICD DVBC3D4 Evera XT VR ICD DVBB1D4 M Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-06-25 P010031-S922 Amplia MRI CRT-D DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava Quad CRT-D DTBC1Q1, DTBC1QQ Cl Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-06-24 P830061-S236 CapSure Sense Lead (4074), CapSure Sense Lead (4574), Vitatron Crystalline Lead (ICM09B, ICM09JB) 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-06-24 P030036-S160 SelectSecure Lead (3830) 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-05-28 P030036-S158 SelectSecure Lead Model 3830 Normal 180 Day Track NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-05-15 P980016-S958 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-05-15 P010031-S925 Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRTD (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Cobalt X 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-04-30 P980016-S957 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-04-30 P980016-S951 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2DL DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI IC Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-04-30 P010031-S924 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-04-30 P010031-S918 Cobalt MRI CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome M Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-04-28 P980016-S956 Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI DR ICD, Primo MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-04-28 P010031-S923 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-04-15 P900061-S176 End Cap (6701), Sizing Sleeve (6920), Upsizing Sleeve (6925) 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-04-15 P850089-S174 CapSure SP Novus Lead (5092); CapSure SP Novus Lead (5592); CapSure SP Novus Lead (5594); CapSure SP Z Lead, CapSure Z N 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-04-15 P830061-S235 Adhesive; CapSure Sense Lead (4073,4074); CapSure Sense Lead (4574); CapSure SP Novus Lead (4092); CapSure SP Novus Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-04-15 P030036-S159 Anchoring Sleeve Kit; SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-03-27 P980016-S954 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-03-27 P010031-S921 Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-03-06 P980016-S953 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR I CD; Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-03-06 P030036-S157 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-03-06 P010031-S920 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-03-04 P980016-S952 Cobalt MRI ICD (DDPB3Dl, DDPB3D4, DVPB3Dl, DVPB3D4); Cobalt XT MRI ICD (DDPA2Dl, DDPA2D4, DVPA2Dl, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-03-04 P010031-S919 Cobalt MRI CRT-D (DTPB2Dl, DTPB2D4, DTPB2Ql, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2Dl, DTPA2D4, DTPA2Ql, DTPA2QQ); Crome M 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-02-12 P980016-S949 Evera MRI DF-1 ICD DDMB1D1, DDMC3D1, DVMB1D1, DVMC3D1 Evera MRI ICD DDMB1D4, DDMC3D4, DVMB1D4, DVMC3D4 Evera S DR ICD DD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-02-12 P010031-S916 Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-02-11 P980016-S947 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; Mirro 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-02-11 P010031-S914 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-02-10 P980016-S948 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-02-10 P850089-S173 CapSure SP Novus Lead 5092 CapSure SP Z Lead 5033 Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-02-10 P830061-S233 CapSure Sense Lead 4574 CapSure Sense Lead 4073, 4074 Vitatron Crystalline Lead ICM09, ICM09B, ICM09JB Vitatron Excellen 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-02-10 P030036-S156 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-02-10 P010031-S915 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-01-23 P980016-S945 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-01-23 P010031-S912 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-01-16 P980016-S946 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-01-16 P010031-S913 Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2026-01-08 P030036-S155 SelectSecure Lead 3830 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2026-01-05 P980016-S944 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4 Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4 Crome MRI ICD DDP 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2026-01-05 P010031-S911 Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1, DTBC1D4 Brava Quad CRT-D D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-12-19 P010031-S905 Cobalt MRI CRT-D DTPB2D1, DTPB2D4 NIK Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4 NIK Crome MRI CRT-D DTPC2D1, DTPC2D4 Normal 180 Day Track NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-12-15 P980016-S942 Cobalt MRI ICD DDPB3D4, DVPB3D4; Cobalt XT MRI ICD DDPA2D4, DVPA2D4; Crome MRI ICD DDPC3D4, DVPC3D4; Evera MRI DF-1 ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-12-15 P010031-S909 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; Claria MRI Quad CRT-D; Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-12-03 P980016-S943 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-12-03 P980016-S941 Cobalt MRI ICD DVPB3D1, DDPB3D1, DDPB3D4, DVPB3D4 LWS, NVZ Cobalt XT MRI ICD DVPA2D1, DVPA2D4, DDPA2D1, DDPA2D4 LWS, NVZ 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-12-03 P980016-S940 Cobalt MRI ICD; Cobalt XT MRI ICD ; Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-12-03 P010031-S910 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-12-03 P010031-S908 Amplia MRI CRT-D DTMB1D1, DTMB1D4, Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ NIK Brava CRT-D DTBC1D1 KRG, NIK Brava CRT-D D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-12-03 P010031-S907 Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-10-28 P980016-S939 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-10-28 P010031-S906 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-10-09 P030036-S154 MEDTRONIC SELECTSECURE LEAD MODEL 3830 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-10-03 P980016-S938 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-10-03 P980016-S937 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4); Crome MRI I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-10-03 P010031-S904 Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRTD DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI CR 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-10-03 P010031-S903 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-09-15 P980016-S936 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-09-15 P010031-S902 Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-09-09 P980016-S931 Implantable Cardioverter Defibrillator (ICD) Normal 180 Day Track No User Fee LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-09-09 P010031-S897 Cardiac Resynchronization Therapy -Defibrillator (CRT-D) Normal 180 Day Track No User Fee NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-09-05 P980016-S935 Percepta Bipolar CRT-P W1TR1; Percepta Quadripolar CRT-P W4TR01; Serena Bipolar CRT-P W1TR02; Serena Quadripolar CRT-P W 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-09-05 P010031-S901 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-08-12 P980016-S934 Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-08-12 P980016-S932 Cobalt MRI ICD, Cobalt XT MRI ICD, Srome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-08-12 P010031-S900 Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1;Brav 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-08-12 P010031-S898 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-07-29 P980016-S933 Evera MRI DF-1 ICD (DDMB1D1, DVMB1D1, DVMC3D1); Evera MRI DF-1 ICD(DDMC3D1); Evera MRI ICD (DDMB1D4); Evera MRI ICD (DDM 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-07-29 P010031-S899 Amplia MRI CRT-D (DTMB1D1, DTMB1D4); Amplia MRI Quad CRT-D (DTMB1Q1, DTMB1QQ); Brava CRT-D (DTBC1D1, DTBC1D4); Brava Qua 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-07-16 P850089-S172 CapSure SP Z Lead 5033; Vitatron Impulse II Lead IHP09, IHP09B, IHP09JB 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-07-15 P980016-S930 Cobalt MRI ICD (DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4); Cobalt XT MRI ICD (DDPA2D1, DVPA2D1); Cobalt XT MRI ICD (DDPA2D4, D 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-07-15 P010031-S896 Cobalt MRI, CRT-D (DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ); Cobalt XT MRI CRT-D (DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ); Crome 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-07-09 P980016-S929 Cobalt MRI ICD, Cobalt XT MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-07-09 P980016-S926 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-07-09 P010031-S895 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-07-09 P010031-S892 Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-07-02 P980016-S928 VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-07-02 P010031-S894 CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-06-27 P030036-S153 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-06-20 P830061-S231 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-06-18 P980016-S927 Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4; Cobalt XT 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-06-18 P010031-S893 Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4; Brava CRT-D DTBC1D1; Bra 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-06-13 P980016-S925 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1, DVPB3D4; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; Crome MRI ICD D 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-06-13 P010031-S891 Amplia MRI CRT-D DTMB1D1, DTMB1D4; Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ; Brava CRT-D DTBC1D4, Brava CRT-D DTBC1D1; Bra 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-06-05 P980016-S923 Cobalt MRI ICD DDPB3D1; Cobalt MRI ICD DVPB3D1; Cobalt XT MRI ICD DDPA2D1; Cobalt XT MRI ICD DVPA2D1; Crome MRI ICD DDPC 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-06-05 P980016-S913 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 135 Review Track For 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-06-05 P010031-S889 Amplia MRI CRTD DTMB1D1; Amplia MRI Quad CRT-D DTMB1Q1; Brava CRT-D DTBC1D1; Brava Quad CRTD DTBC1Q1; Claria MRI CRT-D D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-06-05 P010031-S879 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 135 Review Track For 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-05-28 P980016-S924 Cobalt MRI ICD DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1, DDPB3D4; Cobalt XT MRI ICD DDPA2D1, DVPA2D1; Cobalt XT MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-05-28 P010031-S890 Cobalt MRI CRT-D DTPB2D1, DTPB2D4, DTPB2Q1, DTPB2QQ; Cobalt XT MRI CRT-D DTPA2D1, DTPA2D4, DTPA2Q1, DTPA2QQ; Crome MRI C 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-04-25 P980016-S922 Cobalt MRI ICD DDPB3D4, DVPB3D1, DVPB3D4; Cobalt MRI ICD DDPB3D1; Cobalt XT MRI ICD DDPA2D1, DDPA2D4, DVPA2D1, DVPA2D4; 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-04-25 P010031-S888 Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D4 Brava CRT-D DTBC1D1 Brava Q 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-04-03 P980016-S921 Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; Evera MRI ICD; Evera S DR ICD; Evera S VR ICD; Evera XT VR ICD; M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-04-03 P010031-S887 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-04-02 P980016-S920 Cobalt MRI ICD DVPB3D4 Cobalt MRI ICD DDPB3D1, DDPB3D4, DVPB3D1 Cobalt XT MRI ICD DDPA2D1, DVPA2D1, DVPA2D4 Cobalt XT MR 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-04-02 P010031-S886 Amplia MRI CRT-D DTMB1D1, DTMB1D4 Amplia MRI Quad CRT-D DTMB1Q1, DTMB1QQ Brava CRT-D DTBC1D1 Brava CRT-D DTBC1D4 Brava Q 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-04-01 P030036-S152 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-03-20 P980016-S918 Virtuso/Entrust/Maximo/Intrinsic/Marquis/Implantable Cardiverter Defibrillators 135 Review Track For 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-03-20 P900061-S175 Medtronic PCD Tachyarrhythmia Control System 135 Review Track For 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-03-20 P850089-S171 Capsure SP, Capsure, Capsure 2 Leads, Excellence S, Impulse, Impulse II Excellence SS, Leads 135 Review Track For 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-03-20 P830061-S230 Steroid TIP(TM) Model 4503 & 4003 Transvenous Pacing 135 Review Track For 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-03-20 P820003-S144 Versatrax Model 7000 Universal A-V Pulse Generator 135 Review Track For 30-Day Notice LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown
2025-03-20 P030036-S151 Medtronic Selectsecure Lead Model 3830 135 Review Track For 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-03-20 P010031-S884 Concerto/Insync Sentry/Insync Maximo Implantable Cardiovascular Defibrillators with Cardiac Resynchicnization 135 Review Track For 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-03-18 P980016-S919 Cobalt MRI ICD; Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD; Evera MRI DF-1 ICD; Evera MRI DF-1 ICD; Evera MRI ICD; 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-03-18 P010031-S885 Amplia MRI CRT-D; Amplia MRI Quad CRT-D; Brava CRT-D; Brava CRT-D; Brava Quad CRT-D; Brava Quad CRT-D; Claria MRI CRT-D; 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-02-26 P980016-S917 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-02-26 P010031-S883 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-02-20 P980016-S897 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD Normal 180 Day Track LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-02-20 P830061-S229 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2025-02-20 P010031-S863 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D Normal 180 Day Track NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-02-14 P980016-S915 Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-02-14 P010031-S881 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-01-30 P980016-S916 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-01-30 P010031-S882 Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt M 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-01-22 P980016-S914 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-01-22 P010031-S880 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-01-14 P980016-S904 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-01-14 P010031-S870 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2025-01-08 P980016-S912 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2025-01-08 P010031-S878 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-12-19 P830061-S228 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-12-18 P980016-S911 Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-12-18 P010031-S877 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-12-10 P980016-S910 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-12-10 P010031-S876 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-12-02 P980016-S909 Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-12-02 P830061-S227 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-12-02 P010031-S875 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-11-27 P980016-S907 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-11-27 P010031-S873 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria Quad MRI CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-11-22 P980016-S908 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-11-22 P010031-S874 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-11-20 P980016-S906 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-11-20 P010031-S872 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-11-14 P980016-S901 CareLink SmartSync Visia AF App, CareLink SmartSync Evera MRI App, CareLink SmartSync Viva Consulta Syncra Advisa Ensura Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-11-14 P010031-S867 CareLink SmartSync Claria Amplia Compia App, CareLink SmartSync Cobalt, Crome App, CareLink SmartSync Viva Brava Evera A Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-11-13 P980016-S905 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-11-13 P900061-S174 End Cap, Epicardial Patch Lead, Sizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-11-13 P850089-S170 CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-11-13 P830061-S226 CapSure Sense Lead, CapSure SP Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-11-13 P030036-S150 Anchoring Sleeve Kit, SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-11-13 P010031-S871 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-10-30 P980016-S902 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-10-30 P010031-S868 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-10-17 P980016-S903 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-10-17 P900061-S173 Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-10-17 P850089-S169 CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-10-17 P830061-S225 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-10-17 P030036-S149 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-10-17 P010031-S869 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-10-01 P850089-S168 CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-10-01 P830061-S224 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-10-01 P030036-S148 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-09-27 P980016-S892 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, 135 Review Track For 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-09-27 P010031-S858 Amolia MRI CRT-D, Amolia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 135 Review Track For 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-09-12 P980016-S900 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-09-12 P010031-S866 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRTD, Cobalt M 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-08-29 P980016-S899 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-08-29 P010031-S865 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-08-28 P980016-S898 Advanced Valve Metal (AVM) capacitor 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-08-28 P030036-S147 Medtronic SelectSecure Lead Model 3830 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-08-28 P010031-S864 Advanced Valve Metal (AVM) capacitor 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-07-31 P830061-S220 CapSure Sense Lead 135 Review Track For 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-07-11 P980016-S896 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-07-11 P010031-S862 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-07-01 P850089-S167 CapSure SP Z Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-07-01 P830061-S223 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-06-17 P980016-S888 Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-06-17 P010031-S854 Cobalt MRI CRTD, Cobalt XT MRI CRT-D, Crome MRI CRT-D Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-06-07 P980016-S895 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-06-07 P010031-S861 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-06-05 P980016-S893 SW016 / Application Software, SWCOMBO / Application Software, SW033 / Application Software 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-06-05 P010031-S859 SW009, SW016, SWCOMBO / Application Software 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-06-04 P980016-S887 HP MRI Application Software, Visia AF Application Software Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-06-04 P010031-S853 CRT-D MRI Application Software, Blackwell Application Software Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-05-29 P980016-S894 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirr 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-05-29 P010031-S860 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-05-23 P980016-S891 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-05-23 P010031-S857 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-05-09 P980016-S881 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-05-09 P010031-S847 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-04-26 P980016-S890 Cobalt XT MRI ICD Normal 180 Day Track No User Fee LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-04-26 P010031-S856 CareLink SmartSync Cobalt, Crome App, Cobalt XT MRI CRT-D Normal 180 Day Track No User Fee NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-04-25 P980016-S889 Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera X 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-04-25 P010031-S855 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-04-16 P830061-S222 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-04-08 P030036-S146 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-04-04 P980016-S886 Aurora EV ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-04-04 P830061-S221 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2024-04-04 P010031-S852 Amplia MRI CRT-D,Amplia MRI Quad CRTD, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D,Cobalt MRI 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-03-11 P980016-S882 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-03-11 P010031-S848 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-03-06 P980016-S885 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-03-06 P010031-S851 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-03-04 P980016-S883 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-03-04 P010031-S849 Cobalt MRI CRT-D, CobaltXT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-03-01 P980016-S884 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-03-01 P010031-S850 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-02-29 P980016-S880 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-02-29 P010031-S846 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-02-27 P820003-S143 External Paulse Generator (EPG) Patient Cable 30-Day Notice LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown
2024-02-16 P980016-S879 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-02-16 P010031-S845 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2024-01-12 P980016-S878 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR IC 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2024-01-12 P010031-S844 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D,Compia M 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-12-15 P980016-S876 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-12-15 P820003-S141 Patient Cable Real-Time Process LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown
2023-12-15 P010031-S842 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-12-14 P820003-S142 Patient Cable 30-Day Notice LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown
2023-12-13 P980016-S875 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-12-13 P980016-S873 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, E 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-12-13 P010031-S841 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRT Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-12-13 P010031-S839 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-12-10 P980016-S877 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI VR ICD, Mirro MRI DR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-12-10 P010031-S843 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-12-07 P980016-S871 EveraMRIDF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S YR ICD, Evera XT YR ICD, Mirro MRI DR ICD, Primo MRI DR ICD, Vi 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-12-07 P010031-S837 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CR T-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-11-29 P980016-S874 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-11-29 P980016-S872 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S, DR ICD, Evera S VR ICD,Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-11-29 P010031-S840 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-11-29 P010031-S838 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI, Compia MRI CRT-D, 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-11-20 P980016-S870 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-11-20 P010031-S836 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-11-03 P980016-S868 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-11-03 P900061-S172 Epicardial Patch Lead 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-11-03 P830061-S219 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-11-03 P030036-S145 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-11-03 P010031-S834 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-11-02 P980016-S869 Viva Quad XT CRTD, Viva XT CRT-D, Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI DF-1 I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-11-02 P010031-S835 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-09-29 P980016-S867 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-09-29 P010031-S833 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-09-22 P980016-S863 CareLink SmartSync Visia AF Application Software, CareLink SmartSync Evera MRI Application Software, Cobalt MRI ICD, Cob Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-09-22 P010031-S829 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, CareLink SmartSync Claria Amplia Compia Applicat Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-09-11 P980016-S861 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-09-11 P010031-S827 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-09-08 P980016-S865 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-09-08 P010031-S831 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-08-28 P980016-S866 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-08-28 P010031-S832 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-08-01 P980016-S864 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-08-01 P900061-S171 Epicardial Patch Lead, Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-08-01 P850089-S166 CapSure SP Novus Lead, CapSure SP Z Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-08-01 P830061-S218 CapSure Sense Lead, CapSure SP Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-08-01 P030036-S144 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-08-01 P010031-S830 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-07-26 P820003-S140 Patient Cable 30-Day Notice LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown
2023-07-17 P980016-S862 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-07-17 P010031-S828 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-07-11 P830061-S217 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-07-05 P980016-S852 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-07-05 P010031-S818 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-06-14 P980016-S860 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-06-14 P900061-S170 End Cap, Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice — — —
2023-06-14 P850089-S165 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-06-14 P830061-S216 CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-06-14 P030036-S143 Anchoring Sleeve Kit, SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-06-14 P010031-S826 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-06-13 P980016-S857 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-06-13 P010031-S823 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-06-09 P980016-S859 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-06-09 P010031-S825 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-06-06 P980016-S856 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-06-06 P010031-S822 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-05-26 P830061-S213 CapSure Sense Lead, Vitatron Crystalline Lead Real-Time Process NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-05-23 P830061-S215 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-05-17 P980016-S855 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-05-17 P010031-S821 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-05-16 P980016-S854 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-05-16 P010031-S820 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-04-12 P980016-S853 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-04-12 P980016-S850 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-04-12 P010031-S819 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-04-12 P010031-S817 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-03-28 P850089-S164 CapSure SP Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-03-28 P830061-S214 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-03-28 P030036-S142 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-03-24 P980016-S851 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-03-24 P010031-S816 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-03-14 P980016-S849 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-03-14 P010031-S815 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-03-07 P980016-S843 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-02-23 P980016-S844 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-02-23 P010031-S810 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-02-17 P830061-S212 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-02-08 P980016-S842 Evera S, Evera XT, Maximo II, Protecta, Protecta XT, Secura, Virtuoso II, Cobalt, Cobalt XT, Crome, Crome XT Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-02-08 P010031-S809 Brava, Brava Quad, Concerto II, Consulta, Maximo II, Protecta, Protecta XT, Viva Quad C, Viva Quad S, Viva Quad XT, Viva Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-02-06 P980016-S848 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-02-06 P010031-S814 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-02-03 P980016-S847 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-02-03 P010031-S813 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-01-26 P980016-S846 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, E 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-01-26 P010031-S812 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2023-01-16 P830061-S211 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2023-01-13 P980016-S845 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2023-01-13 P010031-S811 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-11-28 P030036-S141 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-11-22 P980016-S841 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-11-22 P850089-S163 CapSure SP Novus Lead, CapSure SP Z Lead and Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-11-22 P830061-S210 CapSure Sense Lead and Vitatron Crysatlline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-11-22 P030036-S140 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-11-22 P010031-S808 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-11-03 P980016-S839 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-11-03 P010031-S805 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-10-25 P980016-S840 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-10-25 P830061-S209 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-10-25 P010031-S806 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-10-20 P980016-S838 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, Mirro MRI DR/VR ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-10-20 P010031-S804 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-10-14 P980016-S837 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-10-14 P010031-S803 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-10-06 P980016-S830 CareLink SmartSync Evera MRI Application, CareLink SmartSync Visia AF Application Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-10-06 P010031-S796 CareLink SmartSync Viva Brava Evera Application, CareLink SmartSync Claria Amplia Compia Application Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-10-03 P030036-S139 Medtronic SelectSecure™ MRI SureScan™ Lead Normal 180 Day Track NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-09-19 P980016-S836 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-09-19 P980016-S835 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-09-19 P010031-S802 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-09-19 P010031-S801 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-09-15 P830061-S208 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-08-29 P980016-S833 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-08-29 P010031-S799 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-08-26 P980016-S825 Evera MRI XT DR SureScan Model DDMB1D4, Evera MRI XT VR SureScan Model DVMB1DA, Evera MRI S DR SureScan Model DDMC3D4, E Normal 180 Day Track No User Fee LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-08-25 P980016-S834 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-08-25 P010031-S800 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-08-16 P980016-S832 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-08-16 P010031-S798 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-08-08 P980016-S831 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-08-08 P010031-S797 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-07-25 P980016-S829 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-07-25 P010031-S795 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-07-20 P980016-S824 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-07-20 P010031-S791 CareLink SmartSync Cobalt/Crome App, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-07-19 P980016-S827 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-07-19 P010031-S793 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-06-29 P980016-S816 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-06-29 P010031-S783 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-06-28 P980016-S826 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-06-28 P010031-S792 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-06-01 P980016-S823 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-06-01 P900061-S169 ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-06-01 P850089-S162 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-06-01 P830061-S207 Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-06-01 P030036-S138 Anchoring Sleeve Kit, SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-06-01 P010031-S790 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-05-26 P980016-S820 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-05-26 P010031-S787 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-05-25 P980016-S821 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-05-25 P010031-S788 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-05-20 P980016-S822 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-05-20 P010031-S789 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-05-17 P980016-S819 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-05-17 P010031-S786 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-05-16 P980016-S818 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-05-16 P010031-S785 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-05-03 P980016-S815 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-05-03 P010031-S782 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-04-26 P980016-S814 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-04-26 P010031-S781 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-04-21 P980016-S812 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-04-21 P900061-S168 End Cap, Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-04-21 P850089-S161 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-04-21 P830061-S206 Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-04-21 P030036-S137 Anchoring Sleeve Kit, SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-04-21 P010031-S780 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-04-15 P980016-S811 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-04-15 P010031-S779 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-04-11 P010031-S775 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt Normal 180 Day Track No User Fee NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-04-01 P980016-S810 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-04-01 P010031-S777 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-03-29 P830061-S205 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-03-24 P980016-S809 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-03-24 P010031-S776 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-03-23 P980016-S808 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-03-23 P010031-S774 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-03-14 P830061-S203 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-03-14 P030036-S136 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-02-28 P830061-S204 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-02-25 P980016-S807 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-02-25 P030036-S135 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-02-25 P010031-S773 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-02-22 P980016-S805 Cobalt MRI ICD, Cobalt XT MRI ICD and Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-02-22 P010031-S771 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-02-17 P980016-S806 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-l ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-02-17 P010031-S772 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-02-16 P820003-S139 Patient Cable 30-Day Notice LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown
2022-01-31 P980016-S802 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-01-31 P010031-S768 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-01-28 P980016-S804 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-01-28 P850089-S160 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-01-28 P830061-S202 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2022-01-28 P010031-S770 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-01-24 P010031-S762 CareLink SmartSync™ Cobalt Crome Application Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2022-01-21 P980016-S803 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2022-01-21 P010031-S769 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-12-21 P980016-S801 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-12-21 P010031-S767 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D, 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-12-17 P980016-S799 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-12-17 P010031-S765 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-12-09 P980016-S800 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-12-09 P010031-S766 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-12-07 P980016-S798 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-12-07 P900061-S167 ACE Header End Cap, Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-12-07 P850089-S159 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-12-07 P830061-S200 Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-12-07 P030036-S133 Anchoring Sleeve Kit, SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-12-07 P010031-S764 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-11-30 P980016-S797 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, E 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-11-30 P010031-S763 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-11-24 P830061-S201 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-11-24 P030036-S134 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-11-18 P980016-S796 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-11-18 P010031-S761 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-11-10 P900061-S166 Epicardial Patch Lead 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-11-10 P850089-S158 CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-11-10 P830061-S199 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-11-03 P980016-S795 Cobalt MRI ICD; Cobalt XT MRI ICD; Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-11-03 P010031-S760 Cobalt MRI CRT-D; Cobalt XT MRI CRT-D; Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-10-14 P980016-S794 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-10-14 P010031-S759 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-09-29 P010031-S750 CareLink SmartSync Cobalt, Crome App Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-09-24 P980016-S793 Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-09-24 P010031-S758 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-09-23 P980016-S792 Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD,Crome MRI ICD, Evera MRI DF-1 ICD, E 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-09-23 P010031-S757 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava CRT-D, Brava Quad CRT-D,Brava Quad CRT-D, Claria MRI CRT-D, 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-09-10 P980016-S791 Cobalt MRI ICD, Cobalt MRI ICD, Cobalt XT MRI, Cobalt XT MRI, Crome MRI ICD, Crome MRI ICD,Evera MRI DF-1,Evera MRI DF-1 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-09-10 P010031-S756 Amplia MRI CRTD, Amplia MRI Quad, Brava CRT-D, Brava CRT-D, Brava Quad CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Clari 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-09-01 P980016-S790 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-09-01 P010031-S755 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D,Claria MRI Quad CRT-D, Cobalt M 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-08-20 P850089-S157 CapSure SP Novus Lead, CapSure Z Novus Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-08-20 P830061-S198 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-08-20 P030036-S132 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-08-17 P980016-S789 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-08-17 P900061-S165 End Cap, Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-08-17 P850089-S156 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-08-17 P830061-S197 CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-08-17 P030036-S131 Anchoring Sleeve Kit, SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-08-17 P010031-S754 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D,Claria MRI Quad CRT-D, Cobalt M 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-08-16 P010031-S747 CareLink SmartSync Cobalt, Crome Application Normal 180 Day Track NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-08-12 P980016-S788 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera XT DR ICD, Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-08-12 P010031-S753 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D,Claria MRI Quad CRT-D,Cobalt MR 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-07-22 P010031-S752 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, Compia MRI Quad CRT- 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-07-16 P830061-S196 CapSure Sense Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-07-14 P980016-S787 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-07-14 P010031-S751 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-07-02 P980016-S786 Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Pri 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-07-02 P010031-S749 Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-06-29 P980016-S780 Cobalt XT DR ICD MRI SureScan, Cobalt DR ICD MRI SureScan, Crome DR ICD MRI SureScan, Cobalt XT VR ICD MRI SureScan, Cob Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-06-29 P010031-S742 Cobalt XT HF Quad CRT-D MRI SureScan, Coblat HF Quad CRT-D MRI SureScan, Cobalt HF CRT-D MRI SureScan, Crome HF QUad CRT Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-06-23 P850089-S155 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-06-23 P830061-S195 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, Vitatron Excellence PS+ Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-06-16 P980016-S784 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-06-16 P010031-S746 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-06-04 P980016-S785 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-06-04 P010031-S748 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-05-27 P980016-S775 CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-05-27 P010031-S737 CareLink SmartSync Viva Consulta Syncra Advisa Ensura Application Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-05-18 P980016-S783 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-05-18 P010031-S745 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-05-06 P980016-S782 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-05-06 P010031-S744 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CR T-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-05-05 P980016-S774 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-05-05 P010031-S736 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-04-16 P980016-S781 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-04-16 P980016-S768 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI D Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-04-16 P010031-S743 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-04-16 P010031-S730 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-04-12 P980016-S779 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-04-12 P010031-S741 Amplia MRI CRT-D, Amplia MRI Quad CRT_D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, CLaria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-04-08 P980016-S778 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-04-08 P010031-S740 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-04-01 P010031-S728 Amplia MRI Quad CRT-D, Claria MRI Quad CRT-D, Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D Normal 180 Day Track No User Fee NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-03-29 P830061-S194 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-03-25 P980016-S772 Cobalt MRI ICD, Cobalt XT MRI ICD and Crombe MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-25 P010031-S734 Cobaly MRI, XT MRI RT-D and Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-03-16 P980016-S777 Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-16 P010031-S739 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-03-12 P980016-S776 Cobalt MRI ICD, CObalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/SR ICD, Evera XT DR/VR I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-12 P010031-S738 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-03-08 P980016-S771 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-08 P010031-S733 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-03-04 P980016-S769 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-04 P900061-S164 Epicardial Patch Lead 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-04 P850089-S154 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-03-04 P830061-S193 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-03-04 P030036-S130 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-03-04 P010031-S731 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-03-03 P980016-S773 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-03 P980016-S770 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-03-03 P010031-S735 Amplia MRl CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-03-03 P010031-S732 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-02-09 P980016-S764 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-02-09 P850089-S153 CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-02-09 P830061-S192 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-02-09 P030036-S129 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2021-02-09 P010031-S724 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-02-03 P980016-S767 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2021-02-03 P010031-S729 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D and Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2021-01-21 P820003-S138 Patient Cable and Surgical Cable Normal 180 Day Track LWP Implantable Pulse Generator, Pacemaker (Non-Crt) Unknown
2020-12-22 P830061-S189 CapSure Sense Lead Normal 180 Day Track No User Fee NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-18 P980016-S766 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Ev 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-18 P010031-S727 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-12-17 P980016-S759 Protecta ICD, Protecta VR ICD, and Protecta XT ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-17 P010031-S720 Protecta CRT-D and Protecta XT CRT-D Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-12-16 P980016-S763 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-16 P010031-S725 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-12-15 P980016-S765 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR I 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-15 P980016-S762 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-15 P900061-S162 ACE Header, End Cap, Epicardial Patch Lead and Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-15 P850089-S151 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Stylet Kit, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-15 P830061-S187 Adhesive, CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Stylet Kit and Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-15 P030036-S127 Anchoring Sleeve Kit and SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-15 P010031-S726 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-12-15 P010031-S723 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-12-11 P830061-S191 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-10 P830061-S190 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-10 P030036-S125 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-08 P900061-S163 End Cap, Epicardial Patch Lead, and Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-12-08 P850089-S152 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Excellence SS+ Lead, and Vitatron Impulse II Le 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-08 P830061-S188 Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead, and Vitatron Excellence + Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-08 P030036-S128 Anchoring Sleeve Kit and SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-12-03 P030036-S126 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-11-18 P980016-S761 Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-11-18 P980016-S760 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-11-18 P980016-S758 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-11-18 P900061-S161 Epicardial Patch Lead 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-11-18 P850089-S150 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, and Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-11-18 P830061-S186 CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-11-18 P030036-S124 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-11-18 P010031-S722 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-11-18 P010031-S721 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-11-18 P010031-S719 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-11-11 P980016-S757 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-11-11 P010031-S718 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-11-02 P980016-S752 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-11-02 P010031-S713 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-10-22 P980016-S756 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-10-22 P010031-S717 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-10-19 P010031-S711 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-10-15 P830061-S185 CapSure Sense Lead and Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-10-15 P030036-S123 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-09-30 P980016-S755 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-09-30 P010031-S716 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-09-29 P980016-S748 Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Mirro MRI DR ICD, M Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-09-29 P010031-S708 Brava CRT-D, Brava Quad CRT-D, Viva Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, and Viva XT CRT-D Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-09-18 P980016-S754 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-09-18 P010031-S715 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-09-15 P980016-S753 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-09-15 P010031-S714 Cobalt MRI CRT-P, Cobalt XT MRI CRT-D, Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-08-24 P980016-S751 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-08-24 P010031-S712 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-08-06 P900061-S160 Epicardial Patch Lead 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-08-06 P850089-S149 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead and Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-08-06 P830061-S184 CapSure Sense Lead, CapSure SP Novus Lead, and Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-08-06 P030036-S122 Anchoring Sleeve Kit and SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-08-04 P980016-S749 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-08-04 P010031-S709 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-08-03 P980016-S750 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-08-03 P010031-S710 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-07-24 P980016-S742 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-07-24 P010031-S703 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-07-22 P980016-S747 Cobalt MRI ICD, Cobalt XT MRI ICD, Crome MRI ICD, Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Eve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-07-22 P900061-S159 ACE Header, End Cap, Epicardial Patch Lead, Upsizing Sleeve 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-07-22 P850089-S148 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-07-22 P830061-S182 CapSure Sense Lead, CapSure SP Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-07-22 P030036-S121 Anchoring Sleeve Kit, SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-07-22 P010031-S707 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Cobalt 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-07-21 P980016-S746 Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-07-21 P010031-S706 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-07-16 P980016-S745 VIRTUSO/ENTRUST/MAXIMO/INTRINSIC/MARQUIS/IMPLANTABLE CARDIVERTER DEFIBRILLATORS 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-07-16 P010031-S705 CONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-07-10 P830061-S183 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-07-08 P980016-S743 Cobalt MRI ICD, Cobalt XT MRI ICD, and Crome MRI ICD 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-07-08 P010031-S704 Cobalt MRI CRT-D, Cobalt XT MRI CRT-D, and Crome MRI CRT-D 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-06-08 P980016-S741 Cobalt MRI ICD,Cobalt XT MRI ICD,Crome MRI ICD,Evera MRI DF-1 ICD,Evera MRI ICD,Evera S DR ICD,Evera S VR ICD,Evera XT D 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-06-08 P010031-S702 Amplia MRI CRTD-D,Amplia MRI Quad CRT-D,Brava CRT-D,Brava Quad CRT-D,Claria MRI CRT-D,Claria MRI Quad CRT-D,Cobalt MRI C 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-06-02 P900061-S158 Epicardial Patch Lead Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-06-02 P850089-S147 CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead Real-Time Process NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-06-02 P830061-S181 CapSure Sense Lead, CapSure SP Novus Lead Real-Time Process NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-06-02 P030036-S119 SelectSecure Lead Real-Time Process NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-05-27 P980016-S740 Cobalt XT DR MRI SureScan, Cobalt DR MRI SureScan, Crome DR MRI SureScan, Cobalt XT VR MRI SureScan, Cobalt VR MRI SureS 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-05-27 P010031-S701 Cobalt XT HF Quad CRT-D MRI SureScan, Cobalt XT HF CRT-D MRI SureScan, Cobalt HF Quad CRT-D MRI SureScan, Cobalt HF CRT- 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-05-15 P980016-S730 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Intrinsic 30 ICD, M Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-05-15 P010031-S691 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-05-11 P030036-S120 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-05-08 P980016-S731 Visia AF MRI DF1 ICD, Visia AF MRI VR ICD, and Visia AF VR ICD Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-05-08 P010031-S692 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, and Compia MRI Quad Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-05-04 P980016-S739 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-05-04 P010031-S700 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad, Compia MRI, C 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-23 P980016-S738 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-23 P980016-S713 Cobalt XT DR MRI SureScan (DDPA2D4 and DDPA2Dl); Cobalt DR MRI SureScan (DDPB3D4 and DDPB3Dl); Crome DR MRI SureScan (DD Normal 180 Day Track LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-23 P830061-S173 STEROID TIP(TM) MODEL 4503&4003 TRANSVENOUS PACING Normal 180 Day Track NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-04-23 P030036-S111 MEDTRONIC SELECTSECURE LEAD MODEL 3830 Normal 180 Day Track NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-04-23 P010031-S699 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S MRI ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-23 P010031-S674 Cobalt XT HF Quad CRT-D MRI SureScan (DTPA2QQ, DTPA2Q1); Cobalt XT HF CRT-D MRI SureScan (DTPA2D4 and DTPA2Dl); Cobalt H Normal 180 Day Track NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-22 P980016-S737 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Visia AF MRI DF1 IC 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-22 P010031-S698 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MRI CRT-D, Compia MRI Quad CRT- 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-15 P980016-S735 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-15 P010031-S696 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Compia MRI Q 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-14 P980016-S736 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Prot 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-14 P010031-S697 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Compia MRI CRT-D, Compia MRI Q 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-06 P980016-S734 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-06 P980016-S733 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-06 P830061-S180 CapSure Sense Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-04-06 P010031-S695 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-06 P010031-S694 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-04-02 P980016-S732 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR ICD, Mirro MRI VR ICD, Primo MRI 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-04-02 P010031-S693 Amplia MRI CRTD, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRTD, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia MR 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-03-06 P980016-S729 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-03-06 P900061-S157 ACE Header, Epicardial Patch Lead 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-03-06 P850089-S146 Vitatron Impulse II Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-03-06 P830061-S179 CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-03-06 P030036-S118 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-03-06 P010031-S690 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-03-02 P980016-S728 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera VR ICD, Intrinsic 30 ICD, Marq Real-Time Process LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-03-02 P010031-S689 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia Real-Time Process NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-02-03 P030036-S117 Medtronic SelectSecure MRI SureScan Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-01-10 P030036-S116 SelectSecure Lead 30-Day Notice NVN Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes Unknown
2020-01-09 P980016-S726 Evera MRI DF-1 ICD, Evera MRI ICD, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Mirro MRI DR ICD, M 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-01-09 P010031-S687 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D, Claria MRI Quad CRT-D, Compia 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
2020-01-07 P980016-S725 Evera MRI DF-1 ICD, Evera MRI, Evera S DR/VR ICD, Evera XT DR/VR ICD, Mirro MRI DR/VR ICD, Primo MRI DR/VR ICD, Protecta 30-Day Notice LWS Implantable Cardioverter Defibrillator (Non-Crt) Unknown
2020-01-07 P010031-S686 Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI, Claria MRI Quad CRT-D, Compia MRI, C 30-Day Notice NIK Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D) Unknown
Filings

510(k) clearances (none indexed)

Date K-number Device Code Class Specialty
Data source: openFDA · Generated 2026-10-06 10:35 · Last ingest 2026-10-06T14:35:17.195499 · Pipeline: Chrysalis Intelligence