Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·SCULPTRA Aesthetic (injectable poly-L Lactic acid)

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ZENITH FENESTRATED AAA ENDOVASCULAR GRAFT

Prosthesis, Spinous Process Spacer/Plate

FDA Pre-Market Approval

FDA Class 3 ·X-STOP INTERSPINOUS PROCESS DECOMPRESSION (IPD) SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·Autogen, Dynagen, Inogen, Origen NG3 CRT-Ds; Resonate, Vigilant, NG4 CRT-Ds; Acuity , Slit Suture Sleeve Accessory for A

Telescope, Implantable, Miniature

FDA Pre-Market Approval

FDA Class 3 ·VISIONCARE'S IMPLANTABLE MINIATURE TELESCOPE

Neuromodulator For Obesity

FDA Pre-Market Approval

FDA Class 3 ·Maestro Rechargeable System

Temporary Non-Roller Type Left Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella 2.5, Impella CP Systems

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

FDA Pre-Market Approval

FDA Class 3 ·CERAMAX CERAMIC TOTAL HIP SYSTEM

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ACUITY™ Spiral Heart Failure Leads

Implant, Intragastric For Morbid Obesity

FDA Pre-Market Approval

FDA Class 3 ·LAP-BAND ADJUSTABLE GASTRIC BANDING SYSTEM

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·NAVISTAR THERMOCOOL CATHETER

System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy

FDA Pre-Market Approval

FDA Class 3 ·PROLIEVE THERMODILITATION SYSTEM

Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·PROGEL PLEURAL AIR LEAK SEALANT AND PROGEL EXTENDED APPLICATOR SPRAY TIP

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

FDA Pre-Market Approval

FDA Class 3 ·NOVATION CERAMIC ARTICULATION HIP SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MINIMED 530G SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCTIC FRONT CARDIAC CRYOABLATION SYSTEM, ARCTIC FRONT ADVANCE CARDUAC CRYIABKATUIB CATHETER, CRYOCONSOLE AND ACCESSORIE

Occluder, Patent Ductus, Arteriosus

FDA Pre-Market Approval

FDA Class 3 ·PMA NIT-OCCLUD PDA

Ablation System, High Intensity Focused Ultrasound (Hifu), Mr-Guided

FDA Pre-Market Approval

FDA Class 3 ·INSIGHTEC EXABLATE SYSTEM

Bone Grafting Material, Dental, With Biologic Component

FDA Pre-Market Approval

FDA Class 3 ·GEM 21SGROWTH FACTOR ENHANCED MATRIX