Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·EZE-FIT(TM)

Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·COLLAMER UV-ABSORBING POSTERIOR CHAMBER IOL

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve (EBV) System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·SILICON UV-ABSORBING POSTERIOR CHAMBER IOL

Valve, Pulmonary

FDA Pre-Market Approval

FDA Class 3 ·Zephyr Endobronchial Valve System

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS MODELS OF IPG'S: ACTROS, AXIOS, CYLOS, DROMOS, KAIROS, PHILOS/II, PROTOS, ETC.

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·RADIUS CORONARY STENT WITH DELIVERY SYSTEM

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (VENOUS)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (ILIAC)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MAGIC WALLSTENT ENDOPROSTHESIS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS EXPRESS/EXPRESS2 MR & OTW CORONARY STENT SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (TIPS)

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA IOL'S: MODELS EZE-50, 55, 60, 65, 70, P359UV, P366UV, IO359, IO379, S122UV AND L122UV

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ENDOTAK RELIANCE S RX IS-1/EZ IS-1/4-SITE EZ/4-SITE RX LEADS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS (CATARACT)

Stimulator, Neuromuscular, Implanted

FDA Pre-Market Approval

FDA Class 3 ·NEUROCONTROL FREEHAND SYSTEM