Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ALL NON-RATE RESPONSIVE PACEMAKERS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply DR, Esprit SR, Esprit DR

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR 2250, SYMPHONY DR 2550, RHAPSODY SR 2210, RHAPSODY DR 2510, RHAPSODY DR 2530, REPLY ST & REPLY DR PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR AND DR, PARADYM RF VR AND DR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER

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

FDA Pre-Market Approval

FDA Class 3 ·Platinium CRT-D 1711, 1741.

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·BRIO CARDIAC PACEMAKERS DUAL CHAMBER/DUAL CHAMBER RATE RESPONSIVE

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·INSTENSIA ICD

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY/ESPRIT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Orchestra, Orchestra Plus, and Smart Touch programmers

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D

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

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Vega Endocardial Pacing Leads

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·NON-RATE RESPONSIVE PACEMAKERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR / Esprit SR / Reply DR / Esprit DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM (VR/DR) 8750, PARADYM RF (VR/DR) 9750(ZL101),PARADYM RF (VR/DR) 9750 (ZL102),INTENSIA (VR/DR)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY/ESPRIT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ORCHESTRA PROGRAMMER