Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini System

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IM EXCIMER LASER SYSTEM

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini IPG

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ICDs (Implantable Cardioverter Defibrillator) Platinium VR/DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·SMARTVIEW REMOTE MONITORING SYSTEM: SMARTVIEW MONITOR PSTN MODEL, GPRS MODEL

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 ·Platinium VR 1210; Platinium VR 1240; Platinium DR 1510; Platinium DR 1540

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply SR and Reply DR Pacemakers

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·AeroPace® System

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·Optimizer Smart System and Optimizer Smart Mini System

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

FDA Pre-Market Approval

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

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR EXCIMER LASER SYSTEM

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ICDs (Implantable Cardioverter Defibrillator) Platinium VR 1210, 1240; Platinium DR 1510, 1540.

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750,PARADYM DR8750,ISOLINE 2CT-ISOLINE 2CR

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR 8750, PARADYM DR 8750, PARADYM RF CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO2 DR MODEL 624 /ALTO2 VR MODEL 625 ICDS

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BTF/BJF STEROID COLLAR

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)

Excimer Laser System

FDA Pre-Market Approval

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