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

    PMA: P960009 · Supplement: S434 · Decision Aug 10, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Master Activa® Deep Brain Stimulation Therapy System, Percept™ PC BrainSense™
    PMA Number
    P960009
    Supplement Number
    S434
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 10, 2022
    Date Received
    July 11, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Add TSE/Ametek as an alternate supplier for the SenSight Lead Test Cable Kit and SenSight Extension Test Cable Kit.