Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·PRODISC-C TOTAL DISC REPLACEMENT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Aspheric Hydrophobic Acrylic IOL with the AutonoMe Automated Pre-loaded Delivery System, Clareon Toric Aspheric

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·SUPRAANNULAR (S.A.V.) BIOPROSTHESIS MODELS 2650,6650

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21S GROWTH FACTOR ENHANCED MATRIX RHPDGF-BB COMPONENT

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·LOW PRESSURE BIOPROSTHESIS (MODELS 6625LP & 6625)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR Saline-Filled and SPECTRUM Breast Implants

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·PROMETRA PROGRAMMABLE INFUSION PUMP SYSTEM

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SYNCARDIA TEMPORARY CARDIO WEST TOTAL ARTIFICIAL HEART (TAH-T)

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

FDA Pre-Market Approval

FDA Class 3 ·Mentor® MemoryShape® Breast Implants

Extended Depth Of Focus Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon Vivity™ Extended Vision Hydrophobic Intraocular Lens (IOL), Clareon Vivity™ Toric Extended Vision Hydrophobic IO

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Clareon lntraocular Lenses with the AutonoMe Delivery System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS & BIOPROSTHETIC VALVED CONDUIT

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE (THV), MODEL 9600TFX

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHETIV VALVES

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANTS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Inspiris Resilia Aortic Model 11500A