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

    PMA: P010031 · Supplement: S301 · Decision May 10, 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 M4, PROTECTA CRT-D, PROTECTA M4, PROTECTA XT CRT-D, PROTECTA XT M4
    PMA Number
    P010031
    Supplement Number
    S301
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 10, 2012
    Date Received
    April 11, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    UPDATE TO THE VENDOR INSPECTION PROCESS FOR FLEX COMPONENT.