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

    PMA: P010031 · Supplement: S216 · Decision Oct 15, 2010
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II ICD/CONSULTA CRT-D/MAXIMO II CRT-D CONCERTO
    PMA Number
    P010031
    Supplement Number
    S216
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 15, 2010
    Date Received
    September 16, 2010
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A SECOND SUPPLIER FOR THE BPA COMPONENT AND A CHANGE IN THE COMPONENT INSPECTION PROCESS.