Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN 3 TRANSCATHETER HEART VALVE (26MM SIZE ONLY)

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS, 3000/3000TFX AND 3300TFX

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 ·PRODISC L TOTAL REPLACEMENT

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYSHAPE BREAST IMPLANTS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Manta Vascular Closure Device

Filler, Bone Void, Synthetic Peptide

FDA Pre-Market Approval

FDA Class 3 ·AUGMENT Bone Graft and AUGMENT Injectable

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Pericardial Aortic Bioprosthesis; Theon Pericardial Aortic Bioprosthesis with ThermaFix tis

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Sapien 3 Transcatheter Heart Valve

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·Mentor Saline-Filled Breast Implants

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Intuity Elite Valve System

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Aortic Bioprosthesis with ThermaFix tissue process

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve (THV), Edwards SAPIEN 3 Ultra THV, and Edwards SAPIAN 3 Ultra RESILIA THV

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INTUITY Elite Tube Extrusion

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS RESILIA Aortic Valve, KONEC

Artificial Heart

FDA Pre-Market Approval

FDA Class 3 ·SynCardia temporary Total Artificial Heart (TAH-t) System

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·MANTA Vascular Closure Device

Gases Used Within Eye To Place Pressure On Detached Retina

FDA Pre-Market Approval

FDA Class 3 ·UNIPURE C3F8 Ophthalmic Gas in the UNIFEYE Gas Delivery System, UNIPURE C3F8 Ophthalmic Gas in the UNIPEXY Gas Delivery

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS S.A.V. BIOPROSTHESIS MODEL 2650

Percutaneously Delivered Prostheses And Tricuspid Valves

FDA Pre-Market Approval

FDA Class 3 ·Edwards EVOQUE Tricuspid Valve Replacement System