BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S001 · Decision Mar 27, 1998
    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 TREMOR CONTROL SYSTEM
    PMA Number
    P960009
    Supplement Number
    S001
    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, 1998
    Date Received
    November 19, 1997
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    Approval for three of the four conditions of approval, i.e., studies to further characterize long term safety and effectiveness, obtain follow-up mortality and autopsy information, and evaluate patients following implantation of multiple leads and implantation of replacement leads.

    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