Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA VASCULAR SELF-EXPANDING STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT Bioprosthesis, PERIMOUNT Magna Aortic Bioprosthesis, PERIMOUNT Magna Ease Bioprosthesis, PERIMOUNT Plus Biopro

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA (TM) VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3, Ultra 3 Transcatheter Heart Valve

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Transcatheter Heart Valve and SAPIEN 3 Ultra Transcatheter Heart Valve

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM MONORAIL AND OVER THE WIRE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT MAGNA MITRAL EASE PERICARDIAL BIOPROSTHESIS

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·Express® SD Renal Monorail Premounted Stent System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (FORMERLY LIBERTE) CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL BIOPROSTHESIS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Edwards INTUITY Elite Valve, Edwards INTUITY Elite Valve Delivery System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY MEGATRON Everolimus Eluting Platinum Chromium Coronary Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM- MONORAIL AND ION PACLITAXEL-ELUTING CORONAY STENT SYSTEM- OVER THE WIRE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET RHEOLYTIC THROMBECTOMY LF140 CATHETER