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

    PMA: P960009 · Supplement: S235 · Decision Aug 13, 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
    S235
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 13, 2015
    Date Received
    July 14, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF A NEW AUTOMATED INSPECTION PROCEDURE FOR USE IN THE DBS LEAD DISTAL-END STRAIGHTNESS INSPECTION PROCEDURE; THE AUTOMATED INSPECTION SYSTEM IS INTENDED TO REPLACE THE MANUAL INSPECTION PROCEDURE.