Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST PULSE II GENERATOR

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·PARADIGM REAL TIME ? MMT-522/722 INSULIN PUMP

Device, Impotence, Mechanical/Hydraulic

FDA Pre-Market Approval

FDA Class 3 ·COLOPLAST TITAN INFLATABLE PENILE PROSTHESIS

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·EVERFLEX SELF-EXPANDING PERIPHERAL STENT SYSTEM (EVERFLEX)

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·EluNIR™ Ridaforolimus Eluting Coronary Stent System

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

FDA Pre-Market Approval

FDA Class 3 ·R3 delta Ceramic Acetabular System

Lens, Contact, Orthokeratology, Overnight

FDA Pre-Market Approval

FDA Class 3 ·Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT AUSAB

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartMate 3 Left Ventricular Assist System

Stimulator, Autonomic Nerve, Implanted (Depression)

FDA Pre-Market Approval

FDA Class 3 ·VNS THERAPY SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARELINK HOME MONITOR,CARDIOSIGHT READER,CARELINK NETWORK DEVICE DATA MANAGEMENT APPLICATION

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Lutonix Drug Coated Balloon

Drug-Eluting Peripheral Transluminal Angioplasty Catheter

FDA Pre-Market Approval

FDA Class 3 ·Stellarex 035 Drug Coated Balloon Percutaneous Transluminal Angioplasty Catheter

Intravascular Radiation Delivery System

FDA Pre-Market Approval

FDA Class 3 ·NOVOSTE BETA - CATH SYSTEM

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·GORE VIATORR TIPS ENDOPROSTHESIS

Implant, Hearing, Active, Middle Ear, Totally Implanted

FDA Pre-Market Approval

FDA Class 3 ·ESTEEM

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

FDA Pre-Market Approval

FDA Class 3 ·ETI-CORE-IGMK PLUS

Lenses, Soft Contact, Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Pearle Vision Monthly Balance

Automated Insulin Dosing Device System, Single Hormonal Control

FDA Pre-Market Approval

FDA Class 3 ·MiniMed 780G System

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

FDA Pre-Market Approval

FDA Class 3 ·CORETHERM SYSTEM MICROWAVE THERMOTHERAPY