Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit Low Porosity

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Hancock Valved Conduit Modified Orifice

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·SAPIEN 3 TRANSCATHETER HEART VALVE AND ACCESSORIES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS, MODELS 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX,6900, 6900P

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROTHESIS, MODEL 2500P

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS SUPRAANNULAR (S.A.V.) BIOPROSTHESIS, MODEL 2650

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS BIOPROSTHESIS, MODELS 2625

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS DURAFLEX LOW PRESSURE BIOPROSTHESIS MODELS 6625LP AND 6625-ESR-LP

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·SJM BIOCOR VALVE / SJM BIOCOR SUPRA VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TRIFECTA VALVE, VALVE WITH GLIDE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·BIOCOR & EPIC VALVES

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·TRIFECTA VALVE

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN XT TRANSCATHETER HEART VALVE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS WITH THERMAFIX TISSUE PROCESS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTER-EDWARDS PERIMOUNT BIOPROSTHESIS HEART VALVE FAMILIES

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK MODIFIED ORIFICE (MO) VALUED CONDUIT

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK LOW POROSITY VALVED CONDUIT

Intracranial Coil-Assist Stent

FDA Pre-Market Approval

FDA Class 3 ·LVIS and LVIS Jr.

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Ethicon Endo-Surgery Curved Adjustable Gastric Band with Sutureless Port and Applier; Ethicon Endo-Surgery Gastric Band