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

    PMA: P960009 · Supplement: S242 · Decision Dec 23, 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
    S242
    Advisory Committee
    Neurology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 23, 2015
    Date Received
    November 23, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    UPDATE OF THE PULL TEST SAMPLE SIZE AND CONTROL LIMITS USED FOR SPECIAL MANUFACTURING PROCESS MONITORING IN ALIGNMENT WITH THE STATISTICAL PROCESS CONTROL PROGRAM AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN VILLALBA, PUERTO RICO.