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

    PMA: P100027 · Supplement: S038 · Decision Nov 10, 2022
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    INFORM HER2 Dual ISH DNA Probe Cocktail
    PMA Number
    P100027
    Supplement Number
    S038
    Advisory Committee
    Pathology
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    November 10, 2022
    Date Received
    October 14, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Changes to a manufacturing process.