BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Stimulator, Electrical, Implanted, For Parkinsonian Tremor

    PMA: P960009 · Supplement: S081 · Decision Jun 17, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    30
    Registration Numbers
    30

    Basic Information

    Device Name
    Stimulator, Electrical, Implanted, For Parkinsonian Tremor
    Trade Name
    ACTIVA IMPLANTABLE NEUROSTIMULATORS
    PMA Number
    P960009
    Supplement Number
    S081
    Device Class
    FDA Class 3
    Product Code
    MHY
    Generic Name
    Stimulator, electrical, implanted, for parkinsonian tremor
    Medical Specialty
    Unknown
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 17, 2010
    Date Received
    April 15, 2010
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF AN ALTERNATE SUPPLIER FOR THE GOLD PLATING PROCESS.

    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