BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960009 · Supplement: S237 · Decision Dec 21, 2015
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    ACTIVA DEEP BRAIN STIMULATION THERAPY SYSTEM
    PMA Number
    P960009
    Supplement Number
    S237
    Advisory Committee
    Neurology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 21, 2015
    Date Received
    August 31, 2015
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE H2 CATHODE MIX PROCESS USED TO MANUFACTURE BATTERIES FOR IMPLANTABLE DEVICES.