Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·AngioJet Spiroflex Thrombectomy Set, AngioJet Spiroflex VG Thrombectomy Set

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS PORCINE BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·PERIMOUNT PERICARDIAL BIOPROSTHESIS MODELS 2700,2700TFX,2800,2800TFX,3000,3000TFX,6900P PERIMOUNT PLUS AND 6900PTFX

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3 Ultra Transcatheter Heart Valves, Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valves

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS INTUITY Elite Valve System

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN Left Atrial Appendage Closure Technology

Replacement Heart-Valve

FDA Pre-Market Approval

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

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS STENTLESS BIOPROSTHESIS, MODEL 2600P

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VERIFLEX (LIBERTE) BARE-METAL CORONARY STENT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDFIAL AORTIC BIOPROSTHESIS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·SYNERGY EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL MR PREMOUNTED STENT SYSTEM

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN XT Transcatheter Heart Valve