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

FDA Pre-Market Approval

FDA Class 3 ·Platinium CRT-D and Platinium 4LV CRT-D (Cardiac Resynchronization Therapy Defibrillator)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR & DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR/DR 8750 & VR 9750, PARADYM RF DR 9750 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750 (ZL101 & Z102)

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

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741 (IS1) and 1744 (IS4)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY/ESPRIT SR/DR PACEMAKERS

Pulse Generator, Permanent, Implantable

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/DR & RHAPSODY SR/DR

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF CRT-D

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750,PARADYM RF CRT-D 9750 (ZL101), PARADYM RF CRT-D (ZL102)

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR/DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR 6250 & DR 6550 ICDS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ORCHESTRA PROGRAMMER

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply/Esprit (5th generation) Electric Hybrid Module

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM VR 1210, 1240; DR 1510, 1540, CRT-D 1711, 1741

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Programming software modules for Orchestra Plus and SmartTouch programmers, Remote monitoring software

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ORCHESTRA PROGRAMMER