Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·SYNERGYST II PULSE GENERATOR MODELS 7070 & 7071

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart System

Implantable Pacemaker Pulse-Generator

FDA Pre-Market Approval

FDA Class 3 ·Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes

Lymph Node Location System During Sentinel Biopsy Procedure

FDA Pre-Market Approval

FDA Class 3 ·Magtrace/and Sentimag Magnetic Localization System

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

FDA Pre-Market Approval

FDA Class 3 ·Sientra Silicone Gel Breast Implants

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·Axonics Sacral Neuromodulation System

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

FDA Pre-Market Approval

FDA Class 3 ·CONCERTO II. CONSULTA, MAXIMO II, PROTECTA, PROTECTA XT

Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·Oxford™ Cementless Partial Knee System

Solution, Removal, Carries

FDA Pre-Market Approval

FDA Class 3 ·CARIDEX(TM) REMOVAL SYSTEM

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·Resolute Onyx Coronary Stent System

Implantable Pulse Generator

FDA Pre-Market Approval

FDA Class 3 ·OPTIMIZER Smart Mini System

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·InterStim Therapy System, Verify Evaluation System

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·Genesis and EON Family Neurostimulation (IPG) System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ISPHERIC MODEL YA-60BB INTRAOCULAR LENS

Joint, Temporomandibular, Implant

FDA Pre-Market Approval

FDA Class 3 ·TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM

Agent, Absorbable Hemostatic, Collagen Based

FDA Pre-Market Approval

FDA Class 3 ·FLOSEAL HEMOSTATIC MATRIX 5 ML/10 ML KIT

Pump, Infusion, Implanted, Programmable

FDA Pre-Market Approval

FDA Class 3 ·Remodulin

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC(R) HALL PROSTHETIC HEART VALVE

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

FDA Pre-Market Approval

FDA Class 3 ·Cool Point Tubing Set

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CADENCE(R) TIERED THERAPY DEFIBRILLATION SYSTEM