Stimulator, Electrical, Implanted, For Parkinsonian Symptoms

FDA Pre-Market Approval

FDA Class 3 ·Vercise DBS System

Mitral Valve Repair Devices

FDA Pre-Market Approval

FDA Class 3 ·PASCAL Precision implant system: 20000IS and 20000ISM PASCAL Precision guide sheath: 20000GS

Implant, Cochlear

FDA Pre-Market Approval

FDA Class 3 ·HiResolution Bionic Ear System

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

FDA Pre-Market Approval

FDA Class 3 ·DURALOC OPTION CERAMIC HIP SYSTEM

Stimulator, Invasive Bone Growth

FDA Pre-Market Approval

FDA Class 3 ·SPF PLUS-MINI (60UA/W) AND SPF PLUS-MINI (60UA/M)

Stimulator, Electrical, Implanted, For Parkinsonian Tremor

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY

Pulse Generator, Permanent, Implantable

FDA Pre-Market Approval

FDA Class 3 ·Medtronic Revo MRI SureScan IPG and Pacing System

Intraocular Lens

FDA Pre-Market Approval

FDA Class 3 ·OCUCOAT, PMMA AND SILICONE INTRAOCULAR LENSES

System, Endovascular Graft, Aortic Aneurysm Treatment

FDA Pre-Market Approval

FDA Class 3 ·TALENT THORACIC STENT GRAFT SYSTEM

System, Laser, Photodynamic Therapy

FDA Pre-Market Approval

FDA Class 3 ·BLU-U BLUE LIGHT PHOTODYNAMIC THERAPY ILLUMINATOR, MODEL 4170

Temporary Non-Roller Type Right Heart Support Blood Pump

FDA Pre-Market Approval

FDA Class 3 ·Impella RP System

Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

FDA Pre-Market Approval

FDA Class 3 ·MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

Stimulator, Hypoglossal Nerve, Implanted, Apnea

FDA Pre-Market Approval

FDA Class 3 ·Inspire Upper Airway Stimulation

Test, Immunity, Cell Mediated, Mycobacterium Tuberculosis

FDA Pre-Market Approval

FDA Class 3 ·LIAISON QuantiFERON-TB Gold Plus and LIAISON Control QuantiFERON-TB Gold Plus

Stent, Iliac Vein

FDA Pre-Market Approval

FDA Class 3 ·VICI VENOUS STENT System and VICI RDS Stent System

Catheter, Balloon, Urethral, Drug-Coated

FDA Pre-Market Approval

FDA Class 3 ·Optilume Urethral Drug Coated Balloon

Lens, Contact (Rigid Gas Permeable), Extended Wear

FDA Pre-Market Approval

FDA Class 3 ·Paragon CRT (paflufocon B), Paragon CRT 100 (paflufocon D), Paragon CRT Dual Axis (paflufocon D) and Paragon RG-4 (paflu

Shockwave Intravascular Lithotripsy System

FDA Pre-Market Approval

FDA Class 3 ·Shockwave Intravascular Lithotripsy (IVL) System with Shockwave C2 Coronary Intravascular Lithotripsy (IVL) Catheter

Stent, Carotid

FDA Pre-Market Approval

FDA Class 3 ·PROTEGE RX CAROTID STENT SYSTEM

Implantable Cardioverter Defibrillator (Non-Crt)

FDA Pre-Market Approval

FDA Class 3 ·MEDTRONIC MODEL 2696 INCHECK PATIENT ASSISTANT