FDA Pre-Market Approval

CLOSER S(TM) 6FR. SMC DEVICE

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT® Carotid Stent System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (RX & OTW), XIENCE NANO EECSS (RX)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V, XIENCE NANO, PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM (EECSS)

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·AMERICAN EDWARDS LABS HYBRID PTCA CATHETER

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·HYBRID (PTCA) CATHETER

FDA Pre-Market Approval

ACS MULTI-LINK TM CORONARY STENT SYSTEM WITH THE 25MM STENT LENGTH

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ABSOLUTE PRO, ABSOLUTE PRO LL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V & PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Catheters, Transluminal Coronary Angioplasty, Percutaneous

FDA Pre-Market Approval

FDA Class 2 ·ORACLE(TM) CORONARY BALLOON DILATATION CATHETER

FDA Pre-Market Approval

TECHSTAR AND TECHSTAR XL 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·StarClose SE Vascular Closure System

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT Carotid Stent System

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK RX TETRA(TM) CORONARY STENT SYSTEM/ MULTI-LINK OTW TETRA(TM) CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK Ultra Coronary Stent System