Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Edora 8 DR & DR-T, Evity 8 DR-T,Enitra 8 DR-T, Enticos 8 DR-T, Edora 8 SR-T and SR, Evity 8 SR-T, Enitra 8 SR-T,Enticos

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PSW 1601.U Pacemaker/ICD/CRT non implanted components

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS FAMILY, EVIA FAMILY, ENTOVIS FAMILY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·LUMAX 300/340; 500/540; 540 VR-T DX; 600/640;700/740 FAMILY, IFORIA 7/5 FAMILY; ILESTO 7/5/FAMILY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CYLOS , PHILOS, PHILOS II, EVIA, ENTOVIS, EURO EFFECTA, ESTELLA FAMILY

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

FDA Pre-Market Approval

FDA Class 3 ·LUMAS FAMILY

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components PSW 1602.U, HMSC 3.34.0

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non implanted components; PSW 1602.U; HMSC 3.34.0

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

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

FDA Pre-Market Approval

FDA Class 3 ·PHYLAX AV ICD SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·INVENTRA CRT-D

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DRISK RATE ADAPTIVE PACEING SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·STRATOS LV/LV-T CARDIAC RESYNCHRONIZATION THERAPY PACEMAKER (CRP-T) SYSTME

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·IPERIA FAMILY ICD/CRT-D: IPERIA ITREVIA AND INVENTRA

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·DROMOS DR/SR RATE ADAPTIVE PACING SYSTEM

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non-implanted components

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Pulse Generator, Pacemaker, Implantable with Cardiac Resynchronization (CRT-P)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT nonimplanted components

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Pacemaker/ICD/CRT non-implanted components