Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET FAMILY OF THROMBECTOMY SETS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

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

Agent, Absorbable Hemostatic, Non-Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·OXYCELL

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS LIFESCIENCES PERIMOUNT AORTIC AND MITRAL BIOPROSTHESES

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ANGIOJET ULTRA THROMBECTOMY SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

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

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD MONORAIL PREMOUNTED STENT SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision Transcatheter Valve Repair System

Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring

FDA Pre-Market Approval

FDA Class 3 ·FLEXTONE CUTTING BALLOON, H7493BM3XXXXX, H749CBO3XXXXX

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 CORONARY STENT SYSTEM (MONORAIL, MR AND OVER-THE-WIRE, OTW)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·PROMUS ELEMENT PLUS/ PROMUS PREMIER EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS MONORAIL AND OTW CORONARY STENT SYSTEM

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, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·Eluvia Drug-Eluting Vascular Stent System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·ASCENDRA+ DELIVERY SYSTEM, NOVAFLEX+ DELIVERY SYSTEM, EDWARDS EXPANDABLE INTRODUCER SHEATH SET CRIMPER, QUALCRIMP CRIMPI

Replacement Heart-Valve

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS SAPIEN TRANSCATHETER HEART VALVE