BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P980022 · Supplement: S003 · Decision Mar 10, 2000
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P980022
    Supplement Number
    S003
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 10, 2000
    Date Received
    February 14, 2000
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Sen-Serter Auto Inserter to be used with the MiniMed Continuous Glucose Monitoring System as an aid for insertion of the MimiMed Glucose Sensor.