Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus Premier Everolimus-Eluting Platinum Chromium Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY Everolimus Eluting Platinum Chromium Coronary Stent System Monorail (MR) and Over-The-Wire (OTW)

Replacement Heart-Valve

FDA Pre-Market Approval

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

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·AORTIC VALVULOPLASTY BALLOON DILATATION CATHETER

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Innova Vascular Self-Expanding Stent System

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS LD ILIAC PREMOUNTED STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS S.A.V AORTIC PORCINE BIOPROSTHESIS

Pulse-Generator, Program Module

FDA Pre-Market Approval

FDA Class 3 ·BOSTON SCITNTIFIC SCIMED AORTIC VALVULOPLASTY(TM) CATHETER

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX LIBERTE MONORAIL & OTW CORONARY STENT SYSTEM

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·Wallstent (Venous) Endoprosthesis With Unistep Plus Delivery System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·Wallstent (Venous) Endoprosthesis with unistep plus delivery system

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERCARDIAL AORTIC BIOPROSTHESIS, CARPENTIER-EDWARDSPERIMOUNT THEON PERCARDIAL AORTIC BIOPRO

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT TIPS ENDOPROSTHESIS

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS EXPANDABLE INTRODUCER SHEATH SET

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS2 STENT DELIVERY SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·Wallstent TIPS Endoprosthesis with Unistep Plus™ Delivery System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL MONRAIL PREMOUNTED STENT SYSTEM