Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·MISAGO RX Self-expanding Peripheral Stent

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADVISA DR IPG, ADVISA DR MRI IPG, ADVISA SR MRI IPG

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·EBI OSTEOGEN IMPLANTABLE BONE GROWTH STIMULATOR

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Trifecta™ Valve with Glide Technology™

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

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

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·Cobas HPV Test

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON SENOFILCON A BRAND CONTACT LENSES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·IS-1 CONNECTOR TERMINAL OF SELUTE/PICOTIP BIPOLAR LEADS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comflicon A)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR® Pediatric Ventricular Assist Device

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE EPI UNIPOLAR/BIPOLAR LEADS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT, HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·LEAD & Y ADAPTOR/TUNNELING TOOL/TRANSVENE SVC LEAD/SUBCUTANEOUS DEFIBRILLATION LEAD/IS-1 CONNECTOR PORT PIN PLUG KIT

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SENSE/SP NOVUS LEADS/VITATRON CRYSTALLINE/EXCELLENCE+/PS+

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE EXCLUDER AAA ENDOPROSTHESIS

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MODEL 6949 AND 6931 LEADS

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BOSTON EQUALENS, EQUALENS II (ITAFLUROFOCON A)& (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEMS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS/CARBO-SEAL ASCENDING& VALSALVA/ORBIS/OPTIFORM HEART VALVES