Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INGEVITY Active-Fixation Non-MRI / Active-Fixation MRI

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP ABLATION CATHETERS, INTELLATIP MIFI XP ABLATION CATHETERS, ELECTROPHYSIOLOGY CABLES ASSOICATED WITH CARDIAC

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS PULSE GENERATORS - MODELS N118 & N119

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE PATIENT MANAGEMENT SYSTEM INDUCTIVE COMMUNICATOR MODEL 6481 SOFTWARE, VERSION 1.6.

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK P MODEL 16OO

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS/INCEPTA/ENERGEN/PUNCTUA CARDIAC RESYNCHRONIZATION THERAPY-DEFIBRILLATORS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AND MINI ICDS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·SJM BIOCOR/BIOCOR SUPRA VALVES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·INSIGNIA, ALTRUA, INGENIO, ADVANTIO, VITALIO, FORMIO PACEMAKERS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta Valve, Trifecta Valve with Glide Technology (Trifecta GT)

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTTAK AV/PRIZM/PRIZM2,VITALITY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·All Flex 4-Socket Hi-POT/Pulse Test System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK PRX AICD SYSTEM

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COSMOS(TM) SYSTEM

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav MiFi XP Ablation Catheter

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE/RELIANCE S

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav MiFi XP, IntellaNav XP

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER ? ?CRIBRIFORM? OCCLUDER