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

    PMA: P010031 · Supplement: S332 · Decision Sep 20, 2012
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONCERTO II CRT-D. CONSULTA DF-4 ICD, CONSULTA ICD, MAXIMO II CRT-D, MAXIMO II DF-4 CRT-D, PROTECTA CRT-D, PROTECTA DF4
    PMA Number
    P010031
    Supplement Number
    S332
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    September 20, 2012
    Date Received
    August 23, 2012
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    UPDATE ACCEPTANCE CRITERIA INSPECTION PROCESS FOR ALL DIE LOCATIONS ON ALL HYBRIDS.