BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P130017 · Supplement: S060 · Decision Nov 12, 2024
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    COLOGUARD
    PMA Number
    P130017
    Supplement Number
    S060
    Advisory Committee
    Pathology
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 12, 2024
    Date Received
    August 19, 2024
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Supplement P130017_S060 has been approved.