Aid, Surgical, Viscoelastic

FDA Pre-Market Approval

FDA Class 3 ·AMVISC 0.8 ML SYRINGE AND AMVISC PLUS, O.8 ML SYRINGE

Stimulator, Spinal-Cord, Totally Implanted For Pain Relief

FDA Pre-Market Approval

FDA Class 3 ·SCS EXTENSIONS, SCS LEADS, SCS LEADS 1X 8 FAMILY, SCS LEADS PISCES FAMILY, SCS LEADS SPECIFY FAMILY, SCS SCREENING TRAIL

System, Hemodynamic, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CARDIOMEMS

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·XIENCE V AND PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEMS

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·CARBOMEDICS PROSTHETIC HEART VALVE (CPHV)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·AFFINITY/INTEGRITY/VICTORY/ZEPHYR/ACCENT FAMILIES OF PACEMAKERS

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ONE PIECE POSTERIOR CHAMBER IOL

Wearable Automated External Defibrillator

FDA Pre-Market Approval

FDA Class 3 ·LifeVest Wearable Defibrillator

Implant, Dermal, For Aesthetic Use

FDA Pre-Market Approval

FDA Class 3 ·Restylane Injectable Gel

Permanent Pacemaker Electrode

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE(R) AND CAPSURE(R)SP LEADS

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS

System, Appendage Closure, Left Atrial

FDA Pre-Market Approval

FDA Class 3 ·WATCHMAN FLX Pro Left Atrial Appendage Closure (LAAC) Device with Delivery System

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·Deep Brain Stimulation (DBS) Legacy Charger Systems and Accessories

Ventilator, High Frequency

FDA Pre-Market Approval

FDA Class 3 ·MODEL APT 1010 ULTRAHIGH FREQUENCY VENTILATOR

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·ACRYSOF POSTERIOR CHAMBER INTRAOCULAR LENSES

Replacement Heart-Valve

FDA Pre-Market Approval

FDA Class 3 ·CARPENTIER-EDWARDS PERIMOUNT PERICARDIAL AORTIC BIOPROSTHESIS; THEON PERICARDIAL AORTIC BIOPROSTHESIS WITH THERMALFIX TI

Total, Prostate Specific Antigen (Noncomplexed & Complexed) For Detection Of Prostate Cancer

FDA Pre-Market Approval

FDA Class 3 ·VIDAS TOTAL PSA

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·STARCLOSE SE VASCULAR CLOSURE SYSTEM

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·MONOSTRUT CARDIAC VALVE PROSTHESIS

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE SP,Z,Z NOVUS,SP NOVUS