Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X STOP INTERSPINOUS PROCESS DECOMPRESSION SYSTEM

Pulmonary Valve Prosthesis Percutaneously Delivered

FDA Pre-Market Approval

Edwards Alterra Adaptive Prestent System

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·VISTAKON SENOFILCON A CONTACT LENSES FOR EXTENDED WEAR

Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus

FDA Pre-Market Approval

FDA Class 2 ·COBAS AMPLICOR HEPATITIS C VIRUS (HCV) TEST

Intervertebral Fusion Device With Bone Graft, Lumbar

FDA Pre-Market Approval

FDA Class 2 ·RAY TFC UNITE PRODUCT LINE

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PROTEGE GPS AND PROTEGE RX CAROTID STENT SYSTEM

Lipoprotein, Low Density, Removal

FDA Pre-Market Approval

FDA Class 3 ·BLOOD TUBING SYSTEM FOR THE LIPOSORBER LA-15 SYSTEM

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·ATS 3F AORTIC BIOPROSTHESIS

Bronchial Thermoplasty System

FDA Pre-Market Approval

FDA Class 3 ·ALAIR BRONCHIAL THERMOPLASTY SYSTEM

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SALINE FILLED BREST IMPLANTS

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·VARIOUS INSYNC FAMILIES OF CRT-ICDS

Monitor, Skin Resistance/Skin Temperature, For Insulin Reactions

FDA Pre-Market Approval

FDA Class 3 ·DIABETES SENTRY

System, Endovascular Graft, Arteriovenous (Av) Dialysis Access Circuit Stenosis Treatment

FDA Pre-Market Approval

FDA Class 3 ·Covera Vascular Covered Stent

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·Elecsys total PSA

Dorsal Root Ganglion Stimulator For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Axium Neurostimulator System

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

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE/IMMULITE 1000 & IMMULITE 2000 ANTI-HBC

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Ceramic/Metal, Cemented Or Uncemented

FDA Pre-Market Approval

FDA Class 3 ·TRILOGY AB ACETABULAR SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Pearle Vision Monthly Multifocal