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

    PMA: P010031 · Supplement: S370 · Decision May 3, 2013
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO ICD,CONCERTO II CRT-D,CONSULTA DF4 ICD,CONSULTA ICD,INSYNC III MARQUIS ICD,INSYNC MAXIMO ICD,BRAVA CRT-D,VIVA S
    PMA Number
    P010031
    Supplement Number
    S370
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 3, 2013
    Date Received
    April 8, 2013
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF AN UPDATED ACCEPTANCE CRITERION FOR EVALUATION OF INSULATOR MATERIALS USED IN THE MANUFACTURE OF THE SUBJECT ICDS AND CRT-D DEVICES.