Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INVIVE,INTUA CRT-PS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·GUIDANT CONTAK RENEWAL FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY DEVICES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER™ Solid-Tip Ablation Catheter Cable 10’, BLAZER™ Solid-Tip Ablation Catheter Cable 3’, INTELLANAV™ Ablation Cathet

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RX2000(TM) GRAPHICS PROGRAMMER-MODEL 522-06

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SUBCUTANEOUS IMPLANTABLE DEFIBRILLATOR (S-ICD)

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer Septal Occluder and Amplatzer Multi-Fenestrated Septal Occluder

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK(R) P2 ICD FAMILY

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MASTERS VALVED GRAFT WITH HEMASHIELD GRAFT TECHNOLOGY

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM S-ICD Automated Screening Tool

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

FDA Pre-Market Approval

FDA Class 3 ·IntellaNav MiFi XP amd IntellaNav XP

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·INVIVE, INTUA, VISIONIST, VALITUDE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Biocor Valve, Epic Valve, Epic Supra Valve

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL RF HEART FAILURE PULSE GENERATORS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PUNCTUA CRT-DS,COGNIS CRT-DS,ENERGEN CRT-DS,INCEPTA CRT-DS,ORIGEN CRT-DS,INOGEN CRT-DS,DYNAGEN CRT-DS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Septal Occluder, Amplatzer™ Multifenestrated Septal Occluder – “Cribriform”

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta and Trifecta GT Heart Valves

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

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN CRT-D, MOMENTUM CRT-D, MOMENTUM X4 CRT-D, ICD INOGEN CRT-D, ICD DYNAGEN CRT-D, ICD AUTOGEN CRT-D, VIGILANT CR

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·Amplatzer™ Duct Occluder, Amplatzer™ Duct Occluder II, Amplatzer Piccolo™ Occluder