Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·POSTERIOR CHAMBER IOL'S

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·REVISION OPTICS RAINDROP NEAR VISION INLAY

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·VISX EXCIMER LASER SYSTEM MODELS B AND C FOR PHOTOREFRACTIVE KERATECTOMY (PRK)

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·BESTENT 2 OVER-THE-WIRE (OTW)/RAPID EXCHANGE CORONARY STENT DELIVERY SYSTEM

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·SIMPSON CORONARY ATHEROCATH(R) (SCA(TM))DEV.MOD.

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODELS AC-21/AC-21B ANTERIOR CHAMBER IOL

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

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

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·ocufilcon D Soft (Hydrophilic) Extended Wear Contact Lenses

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·Perimount Bioprosthesis, Perimount Magna Aortic Bioprosthesis, Perimount Magna Ease Bioprosthesis, and Perimount Plus Bi

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION SYSTEM

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·ACS MULTI-LINK RX DUET/OTW DUET CORONARY STENT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·POWERLINK STENT GRAFT WITH 17FR. INTUITRAK ACCESSORY DELIVERY SYSTEM

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAR S4 EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·RAPTORRAIL RX SDS, 2.25MM CYPHER STENT

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CADENCE TIERED-THERAPY DEFIBRILLATOR SYSTEM

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·TMR Holmium Laser System

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENT GRAFT

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G INSULIN PUMP

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·HFV STAR