Test, Fluorescence In Situ Hybridization (Fish), For Bladder Cancer Detection And Monitoring For Recurrence

FDA Pre-Market Approval

FDA Class 3 ·UROVYSION BLADDER CANCER KIT

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS/EXPRESS2 MR/OTW CORONARY STENT SYSTEM

System, Test, Her-2/Neu, Nucleic Acid Or Serum

FDA Pre-Market Approval

FDA Class 3 ·VYSIS PATH VYSION HER-2 DNA PROBE KIT

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·CSI (CROFILCON A) EXTENDED WEAR SOFT

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR(R) ROTATIONAL ANGIOPLASTY SYSTEM, TOTABLATOR LASER WELDING PROCESS

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC/AMVISC PLUS SODIUM HYALURONATE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·BOSTON SCIENTIFIC CORPORATION ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES GOLD PLATING PROCESS/FLOPPY GOLD

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EPT 1000TC AND EPT 1000XP CARDIAC ABLATION SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK 1 STANDARD BIOPROSTHETIC VALVE

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·PERMALENS (PERFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ULTRAVIOLET ABSORBING SILICONE POSTERIOR CHAMBER IOL'S

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDE WIRES

Stimulator, Bone Growth, Non-Invasive

FDA Pre-Market Approval

FDA Class 3 ·BIOLECTRON ORTHOPAK BONE GROWTH STIMULAOR & BIOLECTRON SPINALPAK FUSION STIMULATOR

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·IMPLANTABLE PACEMAKER LEAD

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MINIMED CONTINUOUS GLUCOSE MONITORING SYSTEM

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·CARELINK MONITOR MODELS 2490G, 2490H AND 2490J

System, Esophageal Pacing

FDA Pre-Market Approval

FDA Class 3 ·TAPCATH AND TAPSCOPE DISPOSABLE TRANSESOPHAGEAL PROBES

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI COOLED ABLATION SYSTEM