System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AORFIX AAA FLEXIBLE STENT GRAFT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Medtronic CoreValve System / Medtronic CoreValve Evolut R System/ Medtronic CoreValve Evolut PRO System

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·KAMRA INLAY

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·ZIMMER NEXGEN LPS-FLEX MOBILE AND LPS-MOBILE BEARING KNEE SYSTEM

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS TRABECULAR MICRO BYPASS STENT MODEL GTS100R/L

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

FDA Pre-Market Approval

FDA Class 3 ·OVATIO CRT-D SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·SMART-MSP

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SENSAR SOFT ACRYLIC UV-LIGHT ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·BETA-CATH SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·R3 Delta Ceramic Acetabular System

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·ATTAIN ABILITY LV LEAD

Stimulator, Autonomic Nerve, Implanted For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·FORMULA BALLOON-EXPANDABLE RENAL STENT SYSTEM

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS

Prosthesis, Ankle, Uncemented, Non-Constrained

FDA Pre-Market Approval

FDA Class 3 ·SCANDINAVIAN TOTAL ANKLE REPLACEMENT SYSTEM (STAR ANKLE)

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM