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

FDA Pre-Market Approval

FDA Class 3 ·ST JUDE MEDICAL EPIC HF MODEL V-338 AND ATLAS + HF MODEL V-340 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)

Stent, Superficial Femoral Artery, Drug-Eluting

FDA Pre-Market Approval

FDA Class 3 ·ZILVER PTX DRUG-ELUTING PERIPHERAL STENT

Implanted Brain Stimulator For Epilepsy

FDA Pre-Market Approval

FDA Class 3 ·NEUROPACE RNS SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·LCS TOTAL KNEE SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·CyPass Micro-Stent

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·Sprint Quattro Secure and Sprint Quattro Secure S

Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·COROX OTW 75-UP STEROID LEAD, COROS OTW 85-UP STEROID LEAD

Fluid, Intraocular

FDA Pre-Market Approval

FDA Class 3 ·ADATO SIL-OL 5000 SILICONE OIL

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products HBsAg Reagent Pack, Calibrator and Confirmatory Kit

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Integrity Zotarolimus-Eluting Coronary Stent System

Stent, Renal

FDA Pre-Market Approval

FDA Class 3 ·EXPRESS SD RENAL MONORAIL PREMOUNTED STENT SYSTEM

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·REBEL PLATINUM CHROMIUM CORONARY STENT SYSTEM (MONORAIL AND OVER THE WIRE)

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MENTOR SALINE -FILLED & SPECTRUM BREAST IMPLANTS

System, Laser, Transmyocardial Revascularization

FDA Pre-Market Approval

FDA Class 3 ·THE HEART LASER CO2 TMR SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·QuickFlex u 1258T LV Lead

Sealant, Dural

FDA Pre-Market Approval

FDA Class 3 ·DURASEAL (R) EXACT SPINE SEALANT SYSTEM

Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor

FDA Pre-Market Approval

FDA Class 3 ·t:slim G4 Insulin Pump with Dexcom G4 Platinum CGM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·Smartablate System Interface Cable

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator