Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Emblem S-ICD Programmer - Plexus SMT Mfg. Line

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER MUSCULAR VSD OCCLUDER

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II CARDIAC ABLATION CATHETER AND STEEROCATH-T CARDIAC ABLATION CATHETER

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LATITUDE Programming System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Blazer II Cardiac Ablation Catheter and Cable

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICDs: PUNCTUA, ENERGEN, INCEPTA

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·E P TECH EPT-1000 CARDIAC ABLATION SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II TEMPERATURE ABLATION CATHETER, BLAZER II HTD TEMPERATURE ABLATION CATHETER

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

FDA Pre-Market Approval

FDA Class 3 ·INTELLATIP MIFI FILTER MODULE, INTELLATIP MIFI REFERENCE CABLE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL AND CONTAK RENEWAL 3

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM Subcutaneous Implantable Cardioverter Defibrillator (S-ICD)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS PULSE GENERATORS

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

FDA Pre-Market Approval

FDA Class 3 ·Contak CD, Contak Renewal, Livian, Cognis, Energen CRT-D, Punctua CRT-D, Incepta CRT-D, Origen CRT-D, Inogen CRT-D, Dyna

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

FDA Pre-Market Approval

FDA Class 3 ·VALITUDE CRT-P

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER Septal Occluder, AMPLATZER Multi-Fenestrated Septal Occluder

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·EMBLEM Programmer

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL TR PG

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·AMPLATZER DUCT OCCLUDER

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·SJM Masters HP 15mm Rotatable Mechanical Heart Valve (15 AHPJ-505)