Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·VITATRON DIVA PLATFORM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ATLAS IMPLANTABLE CARDIOVERTER DEFIBRILLATOR SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PROVIT MODEL VSA02 VERSION 6.1 SOFTWARE BUILD 63 SERVICE RELEASE FOR DEMA, DIVA AND SELECTION AFM FAMILIES OF PULSE GENS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·META DDDR PACING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·PK-222 and PK-Electrode Clip (accessory to Renamic)

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·EPIC + DR/VR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Tendril MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Assurity MRI, Endurity MRI

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·ST.JUDE MEDICAL ICDS/CRT-D

Permanent Defibrillator Electrodes

FDA classification

FDA Class 3 ·Permanent Defibrillator Electrodes

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA classification

FDA Class 3 ·Aortic Valve, Prosthesis, Percutaneously Delivered

Prosthesis, Mitral Valve, Percutaneously Delivered

FDA classification

FDA Class 3 ·Prosthesis, Mitral Valve, Percutaneously Delivered

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA classification

FDA Class 3 ·Percutaneously Delivered Prostheses And Tricuspid Valves