Sealant, Polymerizing

FDA Pre-Market Approval

FDA Class 3 ·Coseal Surgical Sealant Spray Set

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE Silicone-Filled Breast Implants

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare Ventricular Assist System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EverFlex Self-Expanding Peripheral Stent Systems and EverFlex Self-Expanding peripheral Stent with Entrust Delivery Syst

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Implantable System for Remodulin

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

FDA Pre-Market Approval

FDA Class 3 ·ADVIA Centaur PSA Readypack Reagents

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·ENLITE GLUCOSE SENSORS

Heart-Valve, Non-Allograft Tissue

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE AORTIC ROOT BIOPROSTHESIS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·ENDURANT IIS STENT GRAFT SYSTEM

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·NUCLEUS COCHLEAR IMPLANT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·BLAZER II XP, BLAZER PRIME XP, INTELLATIP MIFI XP SYSTEM CABLES

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·SURGIFOAM ABSORBABLE GELATIN SPONGE & U.S.P./SURGIFLO HEMOSTATIC MATRIX

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM

Pulse-Generator, Single Chamber, Sensor Driven, Implantable

FDA Pre-Market Approval

FDA Class 3 ·MICRONY SR + MODEL 2425T PULSE GENERATOR

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

FDA Pre-Market Approval

FDA Class 3 ·ANTHEM & ANTHEM RF CRT-P'S

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·ACCULINK CAROTID STENT SYSTEM

Automated Insulin Dosing , Threshold Suspend

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 630G System

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·Paradigm REAL-Time Insulin Pump

Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS and Micra TPS

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Astra XT DR MRI IPG, Astra XT SR MRI IPG, Azure S DR MRI IPG, Azure S SR MRI IPG, Azure XT DR MRI IPG, Azure XT SR MRI I