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

    PMA: P960009 · Supplement: S240 · Decision Nov 12, 2015
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    Classifications
    0
    FEI Numbers
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    Registration Numbers
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    Basic Information

    Trade Name
    ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
    PMA Number
    P960009
    Supplement Number
    S240
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 12, 2015
    Date Received
    October 13, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE UPDATE OF MANUFACTURING PROCESS CHANGES IN THE SURFACE TREATMENT OF METAL PIECE PART FOR THE IMPACTED IMPLATABLE PRODUCTS (I.E., TITANIUM, PLATINUM/IRIDIUM ALLOY, AND STAINLESS STEEL SUBCOMPONENTS) AS WELL AS MINOR UPDATES TO THE SURFACE TREATMENT SPECIFICATIONS FOR THESE SUBCOMPONENTS.