Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO AND GALILEO III INTRAVASCULAR RADIOTHERAPY SYSTEMS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·DEXCON SEVEN AND SEVEN PLUS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·enVista® Hydrophobic Acrylic Intraocular Lens (IOL)

Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·CELSIUS DS Catheter, NAVISTAR DS Catheter

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL NAV CATHETER, NAVI-STAR ELECTROPHYSIOLOGY CATHETER & THERMOCOOL SF NAV CATHETER

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS ACRYLIC IOLS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·CYPHER SIROLIMUS-ELUTING CORONARY STENT

Automated External Defibrillators (Non-Wearable)

FDA Pre-Market Approval

FDA Class 3 ·Defibtech Automated External Defibrillator (AED) Systems

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Carpentier-Edwards PERIMOUNT Theon Pericardial Aortic Bioprosthesis with ThermaFix tissue process, Carpentier-Edwards PE

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

Intracranial Aneurysm Flow Diverter

FDA Pre-Market Approval

FDA Class 3 ·Pipeline Flex Embolization Device

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Roche cobas HBV

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·NovaFlex+ Delivery System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·comfilcon A Soft (Hydrophilic) Extended Wear Contact Lenses

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·DURAFLEX LOW PRESSURE PORCINE MITRAL BIOPROSTHESIS, DURAFLEX LOW PRESSURE MITRAL BIOSTHESIS WITH EXTENDED RING

Intrasaccular Flow Disruption Device

FDA Pre-Market Approval

FDA Class 3 ·Woven EndoBridge (WEB) Aneurysm Embolization System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Spectra WaveWriter SCS System, WaveWriter Alpha SCS System, WaveWriter Alpha Prime SCS System

Lens, Multifocal Intraocular

FDA Pre-Market Approval

FDA Class 3 ·TECNIS® 3-Piece Multifocal

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Avalus Bioprosthesis