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

    PMA: P010031 · Supplement: S326 · Decision Aug 30, 2012
    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 II CRT-D, PROTECT
    PMA Number
    P010031
    Supplement Number
    S326
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 30, 2012
    Date Received
    August 3, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    MODIFICATIONS TO A CONTROLLED ENVIRONMENT.