BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P150019 · Decision Dec 7, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME REVEL SYSTEM
    PMA Number
    P150019
    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
    December 7, 2015
    Date Received
    June 10, 2015
    Expedited Review
    N
    Docket Number
    15M-4728

    Advisory Committee Statement

    APPROVAL FOR THE PARADIGM REAL-TIME REVEL SYSTEM. THIS DEVICE IS INDICATED FOR:PARADIGM REAL-TIME REVEL INSULIN PUMP. THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-523/MMT-723) ARE INDICATED FOR THE CONTINUOUS DELIVERY OF INSULIN, AT SET AND VARIABLE RATES, FOR THE MANAGEMENT OF DIABETES MELLITUS IN PERSONS REQUIRING INSULIN. THE PARADIGM REAL-TIME REVEL SYSTEM CONSISTS OF THE PARADIGM MMT-523/MMT-723 INSULIN PUMPS, THE ENLITE GLUCOSE SENSOR (MMT-7008), AND THE MINILINK TRANSMITTER (MMT-7703). USE OF THE PARADIGM MMT-523/MMT-723 INSULIN PUMPS WITH THE OPTIONAL SENSOR AND TRANSMITTER COMPONENTS IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, AND POSSIBLE LOW AND HIGH BLOOD GLUCOSE EPISODES IN ADULTS (AGES 18 AND OLDER). ENLITE SENSOR: THE ENLITE SENSOR (MMT-7008) IS INTENDED FOR USE WITH THE PARADIGM REAL-TIME REVEL INSULIN PUMP SYSTEMS (MMT-523/MMT-723) TO CONTINUOUSLY MONITOR GLUCOSE LEVELS IN PERSONS WITH DIABETES.GLUCOSE VALUES PROVIDED BY THE PARADIGM REAL-TIME REVEL SYSTEM ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR AND NOT ON THE SENSOR GLUCOSE READINGS PROVIDED BY 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