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

    PMA: P030052 · Supplement: S030 · Decision Feb 18, 2026
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    Basic Information

    Trade Name
    UroVysion Bladder Cancer Kit
    PMA Number
    P030052
    Supplement Number
    S030
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    February 18, 2026
    Date Received
    January 21, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of a secondary packaging process