BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960009 · Supplement: S508 · Decision Nov 4, 2025
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    FEI Numbers
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    Basic Information

    Trade Name
    Activa™ Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
    PMA Number
    P960009
    Supplement Number
    S508
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 4, 2025
    Date Received
    June 4, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    implement a change to the Amine Value upper specification limit, correct a typographical error in the Iodine value test method name, and add the initial shelf-life definition