BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S029 · Decision Jul 16, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    MEDTRONIC ACTIVA PARKINSON CONTROL THERAPY
    PMA Number
    P960009
    Supplement Number
    S029
    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
    July 16, 2004
    Date Received
    June 1, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO INCORPORATE A POLYETHER URETHANE MATERIAL CHANGE TO THE APPROVED MEDTRONIC MODELS 3387 AND 3389 DBS LEAD KITS, MODELS 7482 AND 7495 EXTENSION KITS FOR DBS, AND MODEL 3550-09 ACCESSORY KIT.

    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