BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P140020 · Supplement: S029 · Decision Oct 4, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    BRACAnalysis CDx®
    PMA Number
    P140020
    Supplement Number
    S029
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 4, 2024
    Date Received
    June 4, 2024
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval of manufacturing site change for BRACAnalysis CDx®