Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE/CURRENT/FORTIFY FAMILY OF ICDS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Pacemakers (CRT-P) Percepta Bipolar CRT-P, Percepta Quadtripolar CRT-P; Serena Bipolar

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Adapta, Versa, Sensia IPG, Attesta DR/SR MRI IPG, Relia IPG, Sphera DR/SR MRI IPG

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra TPS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INTUITY Elite Valve

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare® Ventricular Assist System, HeartWare® System

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSUREFIX LEAD, CAPSUREFIX NOVUS LEAD, SURFIX LEAD, TORQUE CLIP DEVICE -ACCESSORY FOR 5076 LEAD, VITATRON CRYSTALLINE L

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY FAMILY OF PACEMAKERS

Transcatheter Septal Occluder

FDA Pre-Market Approval

FDA Class 3 ·AmplatzerTM PFO Occluder and AmplatzerTM TalismanTM PFO Occluder

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·CORONARY FLEXTOME CUTTING BALLOON

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

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II/ ANTHEM FAMILY OF CRT-PS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME AND XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CORDIS SEQUICOR THETA MODELS 233D & 233E

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

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

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

FDA Pre-Market Approval

FDA Class 3 ·ARTIC FRONT CRYOABLATION CATHETER,ARTIC FRONT ADVANCE CRYOABLATION CATHETER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT AND ENDURANT II STENT GRAFT SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·CARDIOGENESIS TRANSMYOCARDIAL LASER REVASCULARIZATION SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS