BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P150025 · Supplement: S016 · Decision Feb 28, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    PD-L1 IHC 28-8 pharmDx
    PMA Number
    P150025
    Supplement Number
    S016
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 28, 2025
    Date Received
    January 31, 2025
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for additional quality control tests to raw materials and intermediates that to enhance safety of the finished devices without impacting effectiveness.