BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S089 · Decision Oct 13, 2010
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME REVEL INSULIN PUMP
    PMA Number
    P980022
    Supplement Number
    S089
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 13, 2010
    Date Received
    October 4, 2010
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TRADE NAME CHANGE FOR PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K). THE NEW TRADE NAME FOR THESE INSULIN PUMPS IS PARADIGM REAL-TIME REVEL INSULIN PUMP.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MDS Sensor, Glucose, Invasive