Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·OBALON BALLOON SYSTEM

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON - TB GOLD-IN-TUBE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Precision Spinal Cord Stimulator (SCS) Systems

Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise Deep Brain Stimulation (DBS) Systems

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

FDA Pre-Market Approval

FDA Class 3 ·THERAPY DUAL 8 CATHETER AND IBI-1500T6 CARDIAC ABLATION GENERATOR

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·ABIOMED(R) BVS 5000 BI-VENTRICULAR SUPPORT SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CLOSER/CLOSER S SMC 6 FRENCH SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·X-PRESS 6 FRENCH VASCULAR CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE PERCLOSE A-T (AUTO TIE) SMC DEVICE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·X-SITE SUTURE-MEDIATED CLOSURE DEVICE

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE CLOSURE 6 FR., S 6 FR. AND II 6 FR. SUTURE MEDIATED CLOSURE SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE CLOSER II 6FR. SUTURE-MEDIATED CLOSURE (SMC) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·CLOSER / CLOSER S 6 FRENCH SMC SYSTEMS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE PROGLIDE 6 FRENCH SUTURE MEDIATED CLOSURE SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·PERCLOSE A-T MONOFILAMENT 6 FR. SUTURE MEDIATED CLOSURE (SMC) SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·THE CLOSER AK 6 FR. SMC DEVICE

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·SUPERION INTERSPINOUS SPACER