Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PRODIGY IPG

Prosthesis, Breast, Noninflatable, Internal, Silicone Gel-Filled

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MemoryShape Breast Implants

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·VITROS IMMUNODIAGNOSTIC PRODUCTS ANTI-HBSAG REAGENT PACK AND CALIBRATOR

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK PORCINE BIOPROSTHESIS

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

FDA Pre-Market Approval

FDA Class 3 ·Amplia MRI CRT-D, Amplia MRI Quad CRT-D, Brava CRT-D, Brava Quad CRT-D, Claria MRI CRT-D,Claria MRI Quad CRT-D, Cobalt M

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·OXFORD PARTIAL KNEE SYSTEM

Iliac Covered Stent, Arterial

FDA Pre-Market Approval

FDA Class 3 ·GORE VIABAHN VBX Balloon Expandable Endoprosthesis

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·HELISTAT/HELITENE ABSORBABLE COLLAGEN HEMOSTATIC AGENTS

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE VENTRICULAR ASSIST SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·SOFLENS 38 (POLYMACON) SOFT CONTACT LENSES

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·THORATEC VENTRICULAR ASSIST DEVICE

Drug Eluting Permanent Right Ventricular (Rv) Or Right Atrial (Ra) Pacemaker Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CapSure Sense Lead, CapSure SP Novus Lead and Vitatron Crystalline Lead

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·EDWARDS PRIMA PLUS PROCINE STENTLESS BIOPROSTHESTIC VALVES

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

FDA Pre-Market Approval

FDA Class 3 ·REFLECTION CERAMIC ACETABULAR HIPS SYSTEM (RCHS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·TELIGEN, VENTAK PRIZM HE, CONFIENT, & VARIOUS FAMILIES OF VITALITY ICDS

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT™ ILIAC RP Endoprosthesis

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·HANCOCK II PROCINE BIOPROSTHESIS