System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES, CEEON MODELS 911A & 913A, TECNIS MODELS Z9000

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·FOLDABLE ULTRAVIOLET LIGHT-ABSORBING POSTERIOR CHAMBER INTRAOCULAR LENSES (IOLS), CEEON MODELS 911A & 913A, TECNIS Z9000

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR STENT DELIVERY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR PREMOUNTED STENT DELIVERY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR PREMOUNTED STENT DELIVERY SYSTEMS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·NIR ON TM RANGER TM PREMOUNTED STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·VENTAK MINI II+ HE, MINI IV, MINI IV+ PULSE GENERATORS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS2 CORONARY STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·PTCA CATHETERS, NIR PREMOUNTED STENT DELIVERY SYSTEM, AND EXPRESS/EXPRESS 2 CORONARY STENT SYSTEM

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON TB GOLD IN TUBE

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE/+/RF/Q, PROMOTE ACCEL, PROMOTE QUADRA, UNIFY, UNIFY ASSURA, UNIFY QUADRA, QUADRA ASSURA, EPIC+/HF/HF+/II HF/II+H

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)

FDA Pre-Market Approval

FDA Class 3 ·Promote/+/RF/Q, Promote Accel, Promote Quadra, Unify, Unify Assura, Unify Quadra, Quadra Assura, Epic+/HF/HF+/II HF/II+H

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System

Catheter, Sampling, Chorionic Villus

FDA Pre-Market Approval

FDA Class 3 ·TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·iCast Covered Stent System