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

    PMA: P960009 · Supplement: S222 · Decision Apr 2, 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
    S222
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 2, 2015
    Date Received
    March 6, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF AN ADDITIONAL SUPPLIER FOR THE GOLD PREFORMS AND TO INCORPORATE THE USE OF AN ELECTRONIC TRACKING SYSTEM.