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

    PMA: P960009 · Supplement: S234 · Decision Jul 16, 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
    S234
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    July 16, 2015
    Date Received
    June 17, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MANUFACTURING CHANGE TO EXPAND THE UPPER LIMIT OF THE TEMPERATURE RANGE FOR THE CONDITIONING PHASE OF THE STANDARD STERILIZATION CYCLE AT THE MEDTRONIC NEUROMODULATION SULLIVAN LAKE AND RICE CREEK MANUFACTURING FACILITIES.