Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE-FILLED AND SPECTRUM BREAST IMPLANT

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL C11UB ULTRAVIOLET-ABSORBING SILICONE POSTERIOR CHAMBER INTRAOCULAR LENS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·HEPARIN-INDUCED EXTRACORPOREAL LIPOPROTEIN PRECIPITATION (H.E.L.P.) SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MODEL PC-28LB POSTERIOR CHAMBER INTRAOCULAR LENS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ANTERIOR CHAMBER INTRAOCULAR LENS

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·S670 RAPID EXCHANGE CORONARY STENT SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP(R) 2000 SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS LOW PRESSURE BIOPROSTHESIS MODELS 2625 (AORTIC) AD 6625 (MITRAL)

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·IVT CORONARY ATHERECTOMY SYSTEM (TEC)(R)

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ACCULINK & RX ACCULINK CAROTID STENT SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·APS II 3003 PROGRAMMER WITH MODEL 3203A FUNCTION PACK

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC SYNCHROMED INFUSION SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASOSEAL (TM)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC(R) VENTRICULAR ASSIST DEVICE (VAD) SYSTEM

Inhibitor, Peridural Fibrosis (Adhesion Barrier)

FDA Pre-Market Approval

FDA Class 3 ·ADCON -L ADHESION CONTROL IN A BARRIER GEL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TVL(TM) LEAD SYSTEM

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Activa Deep Brain Stimulation Therapy System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System (SNS Urinary Extensions and Leads)