Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINILINK TRANSMITTER, WATERTIGHT TESTER, MINILINK KIT WITH ENLITE SERTER AND MINILINK REPLACEMENT KIT

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·GENESYS HTA SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·JUVEDERM HYALURONATE GEL IMPLANTS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·STARCLOSE & STARCLOSE SE VASCULAR CLOSURE SYSTEMS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·Avalus Bioprosthesis

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·Healon EndoCoat® Ophthalmic Viscosurgical Device (OVD) (3% Sodium Hyaluronate)

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards Commander Delivery System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·CEEON PMMA UV-LIGHT ABSORBING POSTERIOR CHAMBER (IOLS)

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·TLC-II PLUS PORTABLE VAD DRIVER

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS FAMILIES OF PACEMAKERS

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FAMILY OF PACEMAKERS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEM OTW & MULTI-EXCHANGE II (MX2) & RAPID EXCHANGE (RX) DELIVERY SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·HYDROGENICS 60 (OCUFILCON F) UV IMT SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK VISION CORONARY STENT SYSTEM AND MULTI-LINK MINI VISION CORONARY STENT SYSTEM

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·MENTOR POSTERIOR CHAMBER INTRAOCULAR UV ABSORBING PMMA LENSES

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·FRONTIER/FRONTIER II FAMILY OF CRT-P'S

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·DUROMEDICS BILEAFLET HEART VALVE

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER EDWARDS PORCINE BIOPROSTHESIS/CARPENTIER EDWARDS BIOPROSTHETIC VALVED CONDUIT