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

    PMA: P990004 · Supplement: S066 · Decision May 2, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SURGIFLO Hemostatic Matrix, SURGIFLO Hemostatic Matrix Kit with Thrombin
    PMA Number
    P990004
    Supplement Number
    S066
    Advisory Committee
    General, Plastic Surgery
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 2, 2024
    Date Received
    April 5, 2024
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    using molding tool for the luer lock of syringes for the SURGIFLO® Hemostatic Matrix and SURGIFLO® Hemostatic Matrix Kit with Thrombin