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 ·ELA MEDICAL'S REPLY PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D MODEL 8750

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 ·VISX STAR S2 AND S3 EXCIMER LASER SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·SITUS OTW UW28D LEFT VENTRICULAR PACING LEAD

Excimer Laser System

FDA Pre-Market Approval

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM AND IDESIGN ADVANCED WAVESCAN STUDIO

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF VR & RF DR ICD

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM ICDS AND CRT-D DEVICES

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·REPLY DR/SR PACEMAKERS

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

FDA Pre-Market Approval

FDA Class 3 ·INTENSIA CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR/DR AND PARADYM RF VR/DR ICD'S

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY & ELA RHAPSODY PACEMAKERS

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini (OSM) system

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Paradym VR, DR,Paradym RF VR, Paradym RF DR (ZL101),(ZL102),Intensia VR, Intensia DR,Platinium VR 1210, Platinium VR 124

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ELA RATE-RESPONSIVE PACEMAKERS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR ICD, DR ICD, RF VR ICD, RD DR ICD, ORCHESTRA AND ORCHESTRA PLUS PROGRAMMERS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TALENT PULSE GENERATOR MODELS DR233 AND SR 133 AND PROGRAMMER SOFTWARE CSO 4.18 UG

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDesign Refractive Studio