Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·FALOPE-RING (R) BAND CONTRACEPTIVE TUBAL OCCLUSION SYSTEM

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·AB5000/BVS 5000 CIRCULATORY SUPPORT SYSTEM

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER

Fluorescence Imaging For Breast Cancer Detection

FDA Pre-Market Approval

FDA Class 3 ·Lumicell Direct Visualization System (DVS)

Laparoscopic Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ADIANA PERMANENT CONTRACEPTION SYSTEM

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·TMX-2000 BPH THERMOTHERAPY SYSTEM

Implanted Fecal Incontinence Device

FDA Pre-Market Approval

FDA Class 3 ·ACTICON NEOSPHINCTER ARTIFICAL BOWEL SPHINCTER

Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·STAARVISC II SODIUM HYALURONATE

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VICI VENOUS STENT System

Tissue Graft Of 6mm And Greater

FDA Pre-Market Approval

FDA Class 3 ·Artegraft Collagen Vascular Graft

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Avitene Microfibrillar Collagen Hemostat

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ENROUTE Transcarotid Stent System

Reader, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·THINPREP IMAGING SYSTEM

Kit, Dna Detection, Human Papillomavirus

FDA Pre-Market Approval

FDA Class 3 ·CERVISTA HPV 16/18 ASSAY

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·MEDSTREAM PROGRAMMABLE INFUSION SYSTEM CODMAN 3000 SERIES IMPLANTABLE INFUSION PUMP

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA CENTAUR HBSAG & CONFIRMATORY ASSAYS