Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·RX ACCULINK CAROTID STENT SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·EZ STEER THERMOCOOL NAV

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SENSOLOG/DIALOG/REGENCY FAMILY OF PACEMAKERS

Prosthesis, Breast, Inflatable, Internal, Saline

FDA Pre-Market Approval

FDA Class 3 ·MCGHAN MEDICAL SALINE-FILLED BREAST IMPLANTS

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·MINILINK TRANSMITTER (MMT-7703) & IPRO DIGITAL RECORDER (MMT-7709)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·ENDEAVOR ZOTAROLIMUS-ELUTING CORONARY STENT SYSTEMS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT Occluder W Occluder Delivery System

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 630G SYSTEM WITH SMARTGUARD

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

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

Hepatitis Viral B Dna Detection

FDA Pre-Market Approval

FDA Class 3 ·Cobas HBV

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·AQUASEPT II

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis

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

FDA Pre-Market Approval

FDA Class 3 ·Celsius FLTRR, EZ Steer Nav DS Catheter

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·Cardiva VASCADE Family

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·Edwards SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve system

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH Bi-Directional Navigation Catheter, Navigation Catheter

Excimer Laser System

FDA Pre-Market Approval

FDA Class 3 ·STAT S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·VALIANT THORACIC STENT GRAFT WITH THE CAPTIVIA DELIVERY SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·VASCADE VASCULAR CLOSURE SYSTEM

Programmer, Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·3500/3510 PROGRAMMER