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

    PMA: P010031 · Supplement: S317 · Decision Aug 1, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    MAXIMO II DF-4, MAXIMO II, DF-4, PROTECTA DF-4, PROTECTA ICD, PROTECTA XT DF-4, PROTECTA XT ICD, SECURA DF-4, SECURA IC
    PMA Number
    P010031
    Supplement Number
    S317
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    August 1, 2012
    Date Received
    July 3, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGES TO THE RADIO FREQUENCY DEVICE TEST APPLICATION.