Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·DEEP BRAIN STIMULATION FAMILY OF NEUROSTIMULATION LEADS

Shunt, Portosystemic, Endoprosthesis

FDA Pre-Market Approval

FDA Class 3 ·WALLSTENT (TIPS) ENDOPROSTHESIS WITH UNISTEP PLUS DELIVERY SYSTEM

Device, Hemostasis, Vascular

FDA Pre-Market Approval

FDA Class 3 ·DIAGNOSTIC DUETT SEALING DEVICE, MODEL 2200; DIAGNOSTIC DUETT PRO SEALING DEVICE, MODEL 2210; AND D-STAT FLOWABLE HEMOS0

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL RF CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS)

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·CONTAK RENEWAL 3&4 FAMILY OF CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICES

Implantable Pulse Generator, Pacemaker (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·COGNIS FAMILIES

Stent, Superficial Femoral Artery

FDA Pre-Market Approval

FDA Class 3 ·INNOVA VASCULAR SELF-EXPANDING STENT WITH DELIVERY SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·PROTECTA DR/VR/XT DR/VR

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

FDA Pre-Market Approval

FDA Class 3 ·OXFORD PARTIAL KNEE SYSTEM

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·ADAPTA, VERSA, SENSIA, IPG

Heart-Valve, Mechanical

FDA Pre-Market Approval

FDA Class 3 ·Masters Series Mechanical Heart Valve, Regent Mechanical Heart Valve, Masters Series Aortic Valved Graft with Hemashield

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

FDA Pre-Market Approval

FDA Class 3 ·PROSTHESIS, HIP, HEMI-FEMORAL, METAL

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·ICDS: ORIGEN, INOGEN, DYNAGEN, AUTOGEN, RESONATE HF ICD, RESONATE EL ICD, MOMENTUM EL ICD, VIGILIANT EL ICD, PERCIVA HF

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

FDA Pre-Market Approval

FDA Class 3 ·Cardiac Resynchronization Therapy Defibrillator (CRT-D), Dynagen CRT-D/X4 CRT-D, Inogen CRT-D/X4 CRT-D, Origen CRT-D/X4

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire IV IPG

Aortic Valve, Prosthesis, Percutaneously Delivered

FDA Pre-Market Approval

FDA Class 3 ·CoreValve Evolut R and CoreValve Evolut PRO transcatheter aortic valves (TAV)

Prosthesis, Testicular

FDA Pre-Market Approval

FDA Class 3 ·Torosa Saline Filled Testicular Prosthesis

Coronary Drug-Eluting Stent

FDA Pre-Market Approval

FDA Class 3 ·TAXUS LIBERTE PACLITAXEL-ELUTING CORONARY STENT SYSTEM

Permanent Defibrillator Electrodes

FDA Pre-Market Approval

FDA Class 3 ·CAPSURE

Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Metal/Polymer, Mobile Bearing

FDA Pre-Market Approval

FDA Class 3 ·NEXGEN COMPLETE KNEE SOLUTION/LEGACY KNEE - POSTERIOR STABILIZED (LPS)/LPS-FLEX MOBILE BEARING KNEE