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

    PMA: P010031 · Supplement: S306 · Decision Jun 4, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II CRT-D, CONSULTA, CONSULTA DF4, MAXIMO II CRT-D/DF4, PROTECTA CRT-D/DF4/XT CRT-D/XT DF4
    PMA Number
    P010031
    Supplement Number
    S306
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 4, 2012
    Date Received
    May 11, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    INCORPORATE PLATING BAKE TEST AS PART OF THE MONITORING CONTROL PLAN PERFORMED AT THE SUPPLIER.