Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ISOLINE 2CR AND ISOLINE 2CT LEADS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ALIZEA and CELEA pacemakers, Remote monitoring software (RMS)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL RATE-RESPONSIVE PACEMAKERS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR, Reply DR, Esprit SR, and Esprit 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 ·REPLY & ESPRIT SR/DR

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM AND PARADYM RF CRT-D'S

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDesign Refractive Studio

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR Excimer Laser System, WaveScan WaveFront System, and iDesign Advanced WaveScan Studio System

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT & SITUS OTW LV

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CHORUS & OPUS RATE-RESPONSIVE PACEMAKERS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM IMPLANT SOFTWARE VERSION W2.8.4, AND ASSOCIATED PROGRAMMER SOFTWARE SMARTVIEW 2.22UG1

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 (ZL101), PARADYM RF VR 9750, PARADYM RF DR 9750

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 ·Platinium VR 1210,1240 (ICD); Platinium DR 1510, 1540 (ICD)

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; PARADYM RF BCRT-D9750; INTENSIA CRT-D

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System