Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Expandable Introducer Sheath Set

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·RX Herculink Elite Renal and Biliary Stent System

Light Adjustable Lens (Lal) And Light Delivery Device (Ldd)

FDA Pre-Market Approval

FDA Class 3 ·RxSight Light Adjustable Lens and Light Delivery Device

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·STAAR SURGICAL SILICONE UV - ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR XL 10F PERCUTANEOUS VASCULAR SURGICAL SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK FAMILY OF CORONARY STENT SYSTEMS (CSS)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·AFX Endovascular AAA System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SimplifEYE Preloaded Delivery System for enVista Intraocular Lens

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD, SPECTRA, NOVI, MONTAGE MRI & PRECISION MONTAGE SPINAL CORD STIMULATION(SCS) SYSTEMS

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL BREAST IMPLANTS

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

FDA Pre-Market Approval

FDA Class 3 ·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Current, Current Accel, Current+, Ellipse, Fortify, Fortify Assura, Epic/Epic+, Atlas/II/+ family of ICDs

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·IDEAL IMPLANT Structured Breast Implant