Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER OPEN-IRRIGATED ABLATION CATHETER

Implant, Cochlear

FDA Pre-Market Approval

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

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·SJM PACEMAKERS

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA

Stent, Iliac

FDA Pre-Market Approval

FDA Class 3 ·INTRASTENT DOUBLE STRUT STENT

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT AAA STENT GRAFT DELIVERY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·ELEVESS

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

FDA Pre-Market Approval

FDA Class 3 ·ANTI-HBC REAGENT PACK AND CALIBRATOR

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

FDA Pre-Market Approval

FDA Class 3 ·INSYNC MARQUIS MODEL 7277 DUAL CHAMBER ICD SYSTEM

Implant, Corneal, Refractive

FDA Pre-Market Approval

FDA Class 3 ·ReVision Optics Raindrop Near Vision Inlay

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·iStent inject Trabecular Micro-Bypass System (Model G2-M-IS)

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

FDA Pre-Market Approval

FDA Class 3 ·CONTAK CD,EASYTRAK, LIVIAN, COGNIS AND ACUITY SPIRIAL AUTOMATIC IMPLANTABLE CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLL

Lens, Intraocular, Phakic

FDA Pre-Market Approval

FDA Class 3 ·ARTISAN/VERISYSE PHAKIC IOL

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

FDA Pre-Market Approval

FDA Class 3 ·CapSureFix Novus Lead

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

FDA Pre-Market Approval

FDA Class 3 ·STELKAST SURPASS ACETABULAR SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·PROMOTE DEVICES & PROMOTE ACCEL DEVICES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·GORE TAG THORACIC ENDOPROSTHESIS

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·VISIONCARE IMPLANTABLE MINIATURE TELESCOPE

Implant, Hearing, Active, Middle Ear, Partially Implanted

FDA Pre-Market Approval

FDA Class 3 ·VIBRANT SOUNDBRIDGE MIDDLE EAR IMPLANT SYSTEM