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

    PMA: P960009 · Supplement: S227 · Decision Jun 8, 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
    S227
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 8, 2015
    Date Received
    May 11, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    TRANSFER OF INCOMING INSPECTION ACTIVITIES, FOR A NUMBER OF DEVICE COMPONENTS USED IN THE MANUFACTURE OF NEUROMODULATION LEADS, EXTENSIONS AND ACCESSORIES FROM THE MEDTRONIC RICE CREEK MANUFACTURING FACILITY TO MEDTRONIC PUERTO RICO OPERATION CNETERS (MPROC) IN VILLALBA AND JUNCOS.RANSFER OF INCOMING INSPECTION ACTIVITIES.