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

    PMA: P880047 · Supplement: S054 · Decision Feb 28, 2023
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    GYNECARE INTERCEED™ Absorbable Adhesion Barrier
    PMA Number
    P880047
    Supplement Number
    S054
    Advisory Committee
    Obstetrics/Gynecology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 28, 2023
    Date Received
    January 30, 2023
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adding a duplicate cutter equipment for increasing manufacturing capacity due to the transfer of Neuchatel Surgicel fabric and Interceed device manufacturing to Ethicon, LLC, San Lorenzo in Puerto Rico.