Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY SR/DR, RHAPSODY SR/DR, REPLY SR/DR, AND ESPRIT SR/DR PACEMAKERS

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER® Smart Mini

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SMARTVIEW

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

FDA Pre-Market Approval

FDA Class 3 ·CRT-D (CARDIACRESYNCHRONIZATION THERAPY DEFIBRILLATOR)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROGRAMMING SOFTWARE UPGRADE (CSO 4.10 UG)

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR, ISOLINE 2CT STEROID ELUTING PACING LEADS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO VR & DR ICDS

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750, PARADYM RF CRT-D9750 (ZL101), PARADYM CRT-D9750 (ZL102)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDESIGN Refractive Studio

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY 2550 AND 2250 & RHAPSODY 2530, 2510 AND 2210

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Paradym RF VR 9250, Paradym RF DR 9550, Platinium VR 1210, Platinium VR 1240, Platinium DR 1510, Platinium DR 1540

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT-D

Excimer Laser System

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D 8750

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR DEFIBRILLATION LEADS MODELS 2CR5, 2CR6 AND 2CR7

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ELAVIEW 1.26 UG APPLICATION SOFTWARE FOR THE ORCHESTRA PROGRAMMER; RAM PATCHES ALTO P4 AND ALTO2 P3; AND HSO 2.70 SOFTWA