BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S155 · Decision May 14, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL TIME INSULIN PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR.
    PMA Number
    P980022
    Supplement Number
    S155
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    May 14, 2014
    Date Received
    April 14, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    NEW TOOL TO BE USED IN THE PROCESS OF CURING THE VIBRATOR MOTOR TO THE VIBRATOR MOTOR HOUSING IN THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K), A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), A COMPONENT OF THE PARADIGM REAL-TIME REVELCONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING 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