Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·MOBI-C CERVICAL DISC PROSTHESIS (ONE LEVEL)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·GLAUKOS ISTENT TRABECULAR MICRO-BYPASS STENT SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·EVOLENCE COLLAGEN FILLER

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT ABDOMINAL STENT GRAFT SYSTEM

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MIRACLIP CLIP DELIVERY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL CATHETER FOR RADIOFREQUENCY ABLATION

Transcervical Contraceptive Tubal Occlusion Device

FDA Pre-Market Approval

FDA Class 3 ·ESSURE SYSTEM FOR PERMANENT BIRTH CONTROL

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM

Intraocular Pressure Lowering Implant

FDA Pre-Market Approval

FDA Class 3 ·CyPass Micro-Stent

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·Superion Indirect Decompression System

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·EXCOR Pediatric Ventricular Assist Device

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

FDA Pre-Market Approval

FDA Class 3 ·FLAIR ENDOVASCULAR STENT GRAFT

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS CRT-D, LIVIAN CRT-D, CONTAK RENEWAL 3 RF HE CRT-D

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HEARTWARE LEFT VENTRICULAR ASSIST DEVICE SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA AESTHETIC

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·MITRACLIP CLIP DELIVERY SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL SILICONE-FILLED BREAST IMPLANT

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDANCE CONTROLLED ENDOMETRIAL ABLATION SYSTEM

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA