Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM VR/DR

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 ·PARADYM VR 8750,PARADYM DR 8750,PARADYM RF VR 9750,PARADYM RF DR 9750(ZL101),PARADYM RF VR 9750, PARADYM RF DR 9750(ZL10

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·iDesign Advanced WaveScan Studio, STAR Excimer Laser System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELIX II ENDOCARDIAL PACING LEADS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CHORUS(R) MODEL 6001,3,33 DDD MODEL CPRI MODEL P2A

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·MULTI-PARTITION OPERATING ENVIRONMENT FOR ELA PROGRAMMERS

Excimer Laser System

FDA Pre-Market Approval

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

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

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

Pacemaker/Icd/Crt Non-Implanted Components

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF VR 9250 PARADYM RF DR 9550

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMZER Smart Mini IPG Firmware

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Reply Sr, Reply DR, Esprit SR, Esprit DR Pacemakers

Excimer Laser System

FDA Pre-Market Approval

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

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·STELID II BFT/BJF/STELIX BR/STELIX II BRF

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO DR MODEL 6550 AND OVATIO VR MODEL 6260

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT-D, PARADYM RF CRT-D

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PLATINIUM VR / DR / CRT-D

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Alizea and Celea Pacemakers

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ALTO DR ICD

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 RF CRT-D9750 (ZL102), INTENSIA CRT-D 174