Barrier, Absorbable, Adhesion

FDA Pre-Market Approval

FDA Class 3 ·SEPRAFILM ADHESION BARRIER

Test, Prostate Specific Antigen, Free, (Noncomplexed) To Distinguish Prostate Cancer From Benign Conditions

FDA Pre-Market Approval

FDA Class 3 ·ACCESS HYBRITECH FREE PSA REAGENTS ON THE ACCESS IMMUNOASSAY SYSTEMS

Test, Hepatitis B (B Core, Be Antigen, Be Antibody, B Core Igm)

FDA Pre-Market Approval

FDA Class 3 ·ABBOTT AXSYM HBSAG

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·BI-DIRECTIONAL TORQUE WRENCH(MODEL 6942)

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

FDA Pre-Market Approval

FDA Class 3 ·MENTOR MEMORYGEL SILICONE GEL-FILLED BREAST IMPLANTS

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·ANGIO-SEAL VASCULAR CLOSURE DEVICE

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Codman 3000 Series Constant Flow Implantable infusion Pump

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·Helistat Absorbable Collagen Hemostatic Sponge/OraFOAM Absorbable Collagen Hemostatic Sponge

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Prometra Programmable Infusion Pump System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™

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

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator (CRT-D)

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TMJ FOSSA-EMINENCE AND CONDYLAR PROSTHESIS SYSTEM

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·B AND L 70 LIDOFILCON A CONTACT LENSE

Kit, Test, Alpha-Fetoprotein For Neural Tube Defects

FDA Pre-Market Approval

FDA Class 3 ·IMMULITE® AFP, IMMULITE® 2000 AFP

Implanted Electrical Device Intended For Treatment Of Fecal Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Cardiac Ablation Percutaneous Catheter

FDA Pre-Market Approval

FDA Class 3 ·THERMOCOOL SMARTTOUCH SF Catheter

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·RADIESSE INJECTABLE IMPLANT

Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)

FDA Pre-Market Approval

FDA Class 3 ·Stratos LV CRT-P / Stratos LV-T CRT-P / Corox OTW BP Lead / Corox OTW-S BP Lead

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

FDA Pre-Market Approval

FDA Class 3 ·Therapy Dual 8, Therapy 8mm Thermistor, Safire TX Ablation Catheters, 1500T6 RF Generators, 1500T9 RF Generators

Laser, Neodymium:Yag, Ophthalmic For Uses Other Than Posterior Capsulotomy & Cutting Pupillary

FDA Pre-Market Approval

FDA Class 3 ·NEODYMIUM: YAG OPHTHALMIC LASER SYSTEM 9900