Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·OUS Vitatron Application Software

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·OUS Vitatron Application Software

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·OUS HeartTone MRI Application Software

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·EXTENDED WEAR SOFT CONTACT LENS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTILINK ZETA & ULTRA CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ION PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

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

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V, PROMUS & XIENCE NANO EVEROLIMUS ELUTING CORONARY STENT SYSTEMS (EECSS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION/MINIVISION & ML8 CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRME & XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Prosthesis, Hip, Semi-Constrained, Metal/Metal, Resurfacing

FDA Pre-Market Approval

FDA Class 3 ·BIRMINGHAM HIP RESURFACING SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

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

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·VISION RX, MINI VISION RX,MULTILINK 8 CORONARY STENT SYSTEM(CSS)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME EECSS(XIENCE PRIME AND XIENCE PRIME LONG LENGTHS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK ZETA RX CORONARY STENT SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·POSIS ANGIOJET RHEOLYTIC THROMBECTOMY SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·DEPUY CERAMAX CERAMIC TOTAL HIP SYSTEM

Transcatheter Septal Occluder (Atrial)

FDA Pre-Market Approval

FDA Class 3 ·Occlutech ASD Occluder, Occlutech Pistol Pusher (OPP), Occlutech ASD Occluder Procedure Pack

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL DURAL SEALANT SYSTEM