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

    PMA: P010031 · Supplement: S134 · Decision Dec 17, 2008
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INSYNC FAMILIES OF ICDS/CONCERTO CRT-D/MAXIMO II/CONSULTA/CONCERTO II CRT-D
    PMA Number
    P010031
    Supplement Number
    S134
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 17, 2008
    Date Received
    November 20, 2008
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    REDUCTION IN THE SAMPLING FREQUENCY OF ROUTINE ENVIRONMENTAL MONITORING IN THE CONTROLLED ENVIRONMENT ARE AT MEDTRONIC PUERTO RICO OPERATIONS COMPANY IN JUNCOS, PUERTO RICO.