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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S172 · Decision Dec 5, 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 PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP, GUARDIAN REAL-TIME MONITOR
    PMA Number
    P980022
    Supplement Number
    S172
    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
    December 5, 2014
    Date Received
    November 5, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITIONAL MANUFACTURING TESTING TO BE PERFORMED ON A PREVIOUSLY APPROVEDCOMPONENT USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-522,MMT-522K, MMT-722, MMT-722K) AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS(MMT-523, MMT-523K, MMT-723, MMT-723K) THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL SYSTEM RESPECTIVELY. THIS COMPONENT IS ALSO USED IN THE GUARDIAN REAL-TIME MONITOR (CSS7100, CS7100K) THAT IS PART OF THE GUARDIAN REALTIME 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