BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S153 · Decision May 29, 2014
    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
    S153
    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
    May 29, 2014
    Date Received
    March 18, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SOFTWARE CHANGES TO THE PARADIGM REAL-TIME REVELINSULIN PUMP (MMT-523, MMT-523K, MMT-723, AND MMT-723K) APPLICATION SOFTWARE. THESE CHANGES INCLUDE CORRECTIONS FOR TWO MOTOR ERROR ANOMALIES AND ENHANCEMENTS FOR THE THRESHOLD SUSPEND FEATURE, INSULIN VALUE SETTING, AND MERGED COMMON CODE BASE. THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME REVEL SYSTEM.

    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