BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P010031 · Supplement: S156 · Decision Oct 27, 2009
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II CRT-D/CONSULTA CRT-D/MAXIMO II CRT-D
    PMA Number
    P010031
    Supplement Number
    S156
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 27, 2009
    Date Received
    June 2, 2009
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE HYBRID TEST.