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

    PMA: P960009 · Supplement: S509 · Decision Jul 3, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
    PMA Number
    P960009
    Supplement Number
    S509
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 3, 2025
    Date Received
    June 5, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    approval of an addition of a sub-tier supplier, the Knight group, for the slitting process of the aluminum foil, a component used in the production of Restore Small batteries at Medtronic Energy and Component Center (MECC), Brooklyn Center, Minnesota