Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BX VELOCITY STENT ON RAPTORRAIL STENT DELIVERY SYSTEM AND BX VELOCITY STENT WITH HEPACOAT ON RAPTORRAIL STENT DELIVERY

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT CONVERTER STENT GRAFT SYSTEM AND TALENT OCCLUDER SYSTEM

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DuraSeal Dural Sealant System

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ATTAIN ABILITY MODEL 4196 LEFT VENTRICULAR LEAD

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

Dressing, Wound And Burn, Interactive

FDA Pre-Market Approval

FDA Class 3 ·DERMAGRAFT

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·ZILVER PTX DRUG ELUTING PERIPHERAL STENT

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense MRI SureScan Lead

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation Therapy

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·BARD LIFESTENT VASCULAR STENT SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PREVELEAK SURGICAL SEALANT

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cordis® EXOSEAL® Vascular Closure Device

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VAD SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOFINITY CONTACT LENSES

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADDVENT/AFFINITY/IDENTITY/VERITY/INTERGRITY/VICTORY/ZEPHYR/ACCENT/TRILOGY/SYNCHRONY/PARAGONPHOENIX

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RESTYLANE INJECTABLE GEL