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

    PMA: P960009 · Supplement: S241 · Decision Nov 20, 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
    S241
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 20, 2015
    Date Received
    October 29, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    DECREASING THE FREQUENCY OF DESTRUCTIVE ANALYSIS (DA) SAMPLING OF MEDIUM RATE BATTERIES FROM ONCE EVERY 360/180 PARTS (APPROXIMATELY ONCE PER SHIFT) TO EVERY 50 HOURS OR 2400 PARTS RAN, AND THE ADDITION OF FACTORYWORKS MONITORS FOR POWER AND SPOT CHECKS OF THE LASER WELDS AT MEDTRONIC ENERGY AND COMPONENT CENTER (BROOKLYN CENTER, MN).