BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P210001 · Supplement: S012 · Decision Dec 20, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    VENTANA MMR RxDx Panel
    PMA Number
    P210001
    Supplement Number
    S012
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    December 20, 2024
    Date Received
    December 11, 2023
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for assay migration of VENTANA MMR RxDx Panel from the BenchMark ULTRA platform to BenchMark ULTRA PLUS platform.