Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM THERAPY SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·CHILLI II COOLED ABLATION CATHETER AND CABLE

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

FDA Pre-Market Approval

FDA Class 3 ·CapSure SP Novus Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II CARDIAC ABLATION CATHETER AND CABLE

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Gore Excluder AAA Endoprosthesis

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·M6-C Artificial Cervical Disc

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·Obalon Balloon Kit

Stent, Coronary

FDA Pre-Market Approval

FDA Class 3 ·MULTI-LINK 8, MULTI-LINK 8 SV, and MULTI-LINK 8 LL Coronary Stent System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·Akreos One-Piece Acrylic Intraocular Lens (IOL)

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·ON-X PROSTHETIC HEART VALVE

Catheter, Coronary, Atherectomy

FDA Pre-Market Approval

FDA Class 3 ·ROTABLATOR ROTATIONAL ANGIOPLASTY SYSTEM GUIDEWIRE

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTRAK RENEWAL 3

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Consulta CRT-P C4TR01; Syncra CRT-P C2TR01; Viva CRT-P C6TR01

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

FDA Pre-Market Approval

FDA Class 3 ·HeartLight Endoscopic Ablation System

Prosthesis, Intervertebral Disc

FDA Pre-Market Approval

FDA Class 3 ·SYNTHES PRODISC-L TOTAL DISC REPLACEMENT

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·PRECISION SPINAL CORD STIMULATOR (SCS) SYSTEM

Antigen(Complexed),Prostate Specific,(Cpsa)

FDA Pre-Market Approval

FDA Class 3 ·Atellica IM Complexed PSA (cPSA) Assay

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC COREVALVE SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE PRIME, SV, LL; XIENCE Xpedition, SV, LL; Everolimus Eluting Coronary Stent Systems;XIENCE Alpin and Sierra Everol

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·Gore Viabahn Endoprosthesis and Gore Viabahn Endoprosthesis with Heparin Bioactive Surface