Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX STAR EXCIMER LASER SYSTEM

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System (2-Lead configuration)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ALIZEA SR/DR and CELEA SR/DR 1.5T and 3T Full Body MRI conditional pacemakers

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM/PARADYM RF CRT-D

Transvenous Temporary Phrenic Nerve Stimulator

FDA Pre-Market Approval

FDA Class 3 ·AeroPace® System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·ELA MEDICAL IMPLANTABLE CARDIOVERTER DEFIBRILLATORS

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·PARADYM RF VR ICDS

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·Star S4 IR Excimer Laser System

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Implantable Cardioverter Defibrillator (ICD)

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

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 SR/DR, ESPRIT SR/DR

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·Platinium VR and Platinium DR ICD's (Implantable Cardioverter Defobrillator)

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

FDA Pre-Market Approval

FDA Class 3 ·PARADYM CRT

Defibrillator, Implantable, Dual-Chamber

FDA Pre-Market Approval

FDA Class 3 ·OVATIO DR 6550 & OVATIO VR 6250 DEVICES

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

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

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·WAVESCAN WAVEFRONT SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·TALENT MODEL 213 DUAL-CHAMBER, DUAL SENSOR, IMPLANTABLE CARDIAC PACEMAKER, ELA MEDICAL PROGRAMMER