FDA Pre-Market Approval

BOSTON SCIENTIFIC/SCIMED RADIUS CORONARY STENT

FDA Pre-Market Approval

INTERFIX THREADED FUSION DEVICE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·EXPRESSIONS (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TVL LEAD SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·BIOMEDICS 55 (OCUFILCON D) HYDROPHILIC CONTACT LENSES

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·THINLINE(TM)II/FINELINE(TM) II LEADS

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE, U.S.P

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·PRECISION ULTRAVIOLET (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM (ILIAC)

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·BIOSENSE WEBSTER TEMPERATURE CABLES

Dilator, Cervical, Synthetic, Osmotic, Pregnancy Termination

FDA Pre-Market Approval

FDA Class 3 ·LAMICEL OSMOTIC CERVICAL DILATOR

Stent, Central Venous

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS, ILIAC, VENOUS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEMS

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·NELLCOR PURITAN BENNETT INFANT STAR HIGH FREQUENCY VENTILATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·PMMA ANTERIOR CHAMBER INTRAOCULAR LENS

Catheter, Electrode Recording, Or Probe, Electrode Recording

FDA Pre-Market Approval

FDA Class 2 ·CELSIUS/CELSIUS II DIAGNOSTIC ABLATION DEFLECTABLE TIP CATHETER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ANCURE ENDOGRAFT SYSTEM

Lenses, Soft Contact, Daily Wear

FDA Pre-Market Approval

FDA Class 2 ·HYDROCURVE 3 TORIC (BUFILCON A) EXTENDED WEAR SOFT (HYDROPHILIC) CONTACT LENS

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

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITORS, MODELS 2490G AND 2490J

Changer, Tube, Endotracheal

FDA Pre-Market Approval

FDA Class 2 ·ENDOTRACHEAL TUBE CHANGERS