BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S024 · Decision Jul 29, 2002
    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 SYSTEM
    PMA Number
    P960009
    Supplement Number
    S024
    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 29, 2002
    Date Received
    February 25, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Other
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MINOR CHANGES TO THE LABELING OF THE EXISTING MEDTRONIC ACCESS REVIEW MODEL 7438 THERAPY CONTROLLER TO BE USED WITH MEDTRONIC ACTIVA PARKINSON'S CONTROL SYSTEM.

    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