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

    PMA: P030052 · Supplement: S029 · Decision Jan 29, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    UroVysion Bladder Cancer Kit
    PMA Number
    P030052
    Supplement Number
    S029
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    January 29, 2025
    Date Received
    January 8, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    implementation of a new, functionally equivalent normal cell line to manufacture control slides used with the UroVysion Bladder Cancer Kit