BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S051 · Decision Mar 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM
    PMA Number
    P960009
    Supplement Number
    S051
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 27, 2009
    Date Received
    April 24, 2008
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING NEW COMPONENTS AND ACCESSORIES FOR THE ACTIVA RCRECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM:¿ ACTIVA RC, MODEL 37612 (NEUROSTIMULATOR)¿ PATIENT PROGRAMMER, MODEL 37642¿ MODEL 8870 APPLICATION CARD (ACTIVA RC)¿ EXTERNAL NEUROSTIMULATOR, MODEL 37022¿ 8-4 EXTENSION, MODEL 37085¿ ALLIGATOR CLIP SCREENING CABLE. MODEL 3550-67¿ TWIST LOCK SCREENING CABLE, MODEL 3550-68THE ACTIVA RC RECHARGEABLE IMPLANTABLE NEUROSTIMULATION SYSTEM IS INDICATED AS FOLLOWS:MEDTRONIC ACTIVA THERAPY INCLUDES ACTIVA PARKINSON'S CONTROL THERAPY AND ACTIVA TREMORCONTROL THERAPY.PARKINSON'S CONTROL THERAPYBILATERAL STIMULATION OF THE INTERNAL GLOBUS PALLIDUS (GPI) OR THE SUBTHALAMIC NUCLEUS (STN)USING MEDTRONIC ACTIVA PARKINSON'S CONTROL THERAPY IS INDICATED FOR ADJUNCTIVE THERAPY IN REDUCING SOME OF THE SYMPTOMS OF ADVANCED, LEVODOPA-RESPONSIVE PARKINSON'S DISEASE THAT ARE NOT ADEQUATELY CONTROLLED WITH MEDICATION.TREMOR CONTROL THERAPY UNILATERAL THALAMIC STIMULATION BY THE MEDTRONIC ACTIVA TREMOR CONTROL SYSTEM IS INDICATEDFOR THE SUPPRESSION OF TREMOR IN THE UPPER EXTREMITY. THE SYSTEM IS INTENDED FOR USE INPATIENTS WHO ARE DIAGNOSED WITH ESSENTIAL TREMOR OR PARKINSONIAN TREMOR NOT ADEQUATELYCONTROLLED BY MEDICATIONS AND WHERE THE TREMOR CONSTITUTES A SIGNIFICANT FUNCTIONAL DISABILITY.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MHY Stimulator, Electrical, Implanted, For Parkinsonian Tremor