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

    PMA: P950022 · Supplement: S149 · Decision Jun 18, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    Durata 7120, 7121, 7122, 7130, 7131, 7170, 7171, 7120, 7120Q, 7121Q, 7122, 7122Q, 7170Q, 7171Q, 7172Q; Optisure LDA210,
    PMA Number
    P950022
    Supplement Number
    S149
    Advisory Committee
    Cardiovascular
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 18, 2025
    Date Received
    May 29, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    changing the bioburden action level/action limit requirements