Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·OPEN PIVOT AORTIC VALVED GRAFT

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK ICD FAMILIES

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CADENCE, CADET, CONTOUR, ANGSTROM, PROFILE, PHOTON, EPIC, ATLAS, EPIC II, AND ATLAS II ICD FAMILIES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·DELTA, VISTA

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·KAINOX VCS,DF1-C6HV,AND VARIOUS MODELS OF LINOX,EFH, AND PROTEGO LEADS

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·CERVICAL-STIM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V RX EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK MINI VISION CORONARY STENT SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·ICD ORIGEN CRT-D DF4/IS1, DF/IS1/ DF1/IS1/IS4, AND DF4/IS1/IS4, MMENTUM CRT-D IS1 DF4 IS1

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·GYNECARE INTERCEED Absorbable Adhesion Barrier

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Rheolythic Thrombectomy Catheter

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·Wallstent (Venous) Endoprosthesis with Unisteo Plus Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·RELIANCE 4-FRONT Steroid Eluting Leads

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·samaritan Public Access Automated External Defibrillators and Accessories

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Therapy Ablation Catheter, Therapy 4MM Thermistor Ablation Catheter, Therapy Bi-Directional Ablation Catheter

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY™ and SYNERGY™ XD Everolimus-Eluting Platinum Chromium Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·Rotablator Rotational Angioplasty System, ROTAPRO Rotational Artherectomy System, ROTAWIRE Drive