Leadless Pacemaker

FDA Pre-Market Approval

FDA Class 3 ·Micra AV TPS

System, Test, Tumor Marker, For Detection Of Bladder Cancer

FDA Pre-Market Approval

FDA Class 3 ·ALERE NMP22 BLADDERCHECK TEST & CONTROL KIT

Ventricular (Assist) Bypass

FDA Pre-Market Approval

FDA Class 3 ·HeartWare HVAD System

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·LIFESTENT VASCULAR STENT SYSTEMS

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·XACT CAROTID STENT SYSTEM

Sensor, Glucose, Invasive

FDA Pre-Market Approval

FDA Class 3 ·GUARDIAN RT

Device, Thermal Ablation, Endometrial

FDA Pre-Market Approval

FDA Class 3 ·NOVASURE IMPEDENCE CONTROLLED ABLATION SYSTEM

Processor, Cervical Cytology Slide, Automated

FDA Pre-Market Approval

FDA Class 3 ·MONOPREP PAP TEST

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·QUANTIFERON TB GOLD

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·SUPERA PERIPHERAL STENT SYSTEM

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

FDA Pre-Market Approval

FDA Class 3 ·ARCHITECT CORE-M

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Relay Thoracic Stent-Graft With Plus Delivery System

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·Secura DR ICD, Maximo II DR ICD, Protecta XT DR ICD, Protecta DR ICD, Secura VR ICD, Maximo II VR ICD, Protecta XT VR IC

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·TECNIS Symfony Toric Extended Range of Vision IOLs

Stimulator, Electrical, Implantable, For Incontinence

FDA Pre-Market Approval

FDA Class 3 ·INTERSTIM MODEL 3023 AND TRANSCEND MODEL 3726 IMPLANTABLE NEUROSTIMULATORS

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·Valiant Navion Thoracic Stent Graft System

Device, Dermal Replacement

FDA Pre-Market Approval

FDA Class 3 ·INTEGRA DERMAL REGENERATION TEMPLATE - TERMINALLY STERILIZED (IDRT-TS)

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE LEAD

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

FDA Pre-Market Approval

FDA Class 3 ·NATRELLE SILICONE-FILLED BREAST IMPLANTS

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC INSYNC (TM) BIVENTRICAL PACING SYSTEM