Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRIZM VR, PRIZM DR, PRIZM HE VR, PRIZM HE DR, PRIZM 2 VE, PRIZM 2 DR, PRIZM AT ICDS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750, PARADYM DR 8750, PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL102), INTENSIA VR ICD, INTENSIA DR

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 7303 INSYNC MAXIMO DUAL CHAMBER ICD SYSTEM AND MODEL 9998 APPLICATION SOFTWARE VERSION 1.0 FOR THE MODEL 2090 PROG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENTRUST/INTRINSIC/MARQUIS/MAXIMO/II/II/II M4/PROTECTA/XT/PROTECT XT M4/PROTECTA M4/SECURA/SECURA M4/VIRTUOSO/II ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Paradym VR, Paradym DR, Paradym RF VR, Paradym RF DR (ZL 102) Intensia VR ICD, Intensia DR, Platinium VR, Platinium DR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF ICD'S, GEM FAMILY, MICRO JEWEL II, MICRO JEWEL, JEWEL AND JEWEL PLUS FAMILY, PCD FAMILY,JEWEL CD 720

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO ICD, CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D, PROTECTA CRT-D, PROTECTA DF-DF-4, PROTECTA XT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR & SR,, EVERA XT DR & VR , MAXIMO II, PROTECTA , PROTECTA XT, SECURA, & VIRTUOSO II DR/VR ICD'S

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Various models of dual chamber ICDS in the Ilivia, Intica, Inlexa Families, Various models of CRT-Ds and Non- CRT-Ds in

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, VR,; EVERA XT DR, EVERA XT VR , MAXIMO II , PROTECTA , PROTECTA XT, SECURA; AND VIRTUOSO II D/RVR ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA MRI, EVERA S DR, EVERA S VR, EVERA XT DR, EVERA XT VR, VISIA AF MRI VR, VISIA AF VR ICD.

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR,EVERA S VR,EVERA XT DR,EVERA XT VR,MAXIMO II,PROTECTA,PROTECTA XT,SECURA,VIRTUOSO II DR/VR ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR, EVERA XT DR,EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·QUICKSITE/QUICKFLEX LEADS/EPIC HF/+HF/EPIC II HF/II + HF/ATLAS HF/+ HF/II HF/II + HF/PROMOTE/PROMOTE + ICDS/CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EVERA S DR, EVERA S VR,EVERA XT DR, EVERA XT VR, MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II DR/VR ICDS

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·BELOS DR/DR-T/VR/VR-T, LEXOS DR/DR-T/VR/VR-T, LUMOS DR-T/VR-T, XELOS DR-T ICD'S

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ST. JUDE MEDICAL EPIC DR/VR/HF, EPIC+ DR/VR, EPIC II/II+ DR/VR/HR, ATLAS, ATLAS+, AND ATLAS II/II+ ICD SYSTEMS