BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S146 · Decision Nov 23, 2015
    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
    PMA Number
    P980022
    Supplement Number
    S146
    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
    November 23, 2015
    Date Received
    November 8, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES IN THE WELDING PROCESS OF THE CLEAR PLASTIC WINDOW TO THE PUMP CASE OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K) AND THE MINIMED 530G INSULIN PUMP (MODEL: MMT-551). THE PARADIGM REAL-TIME INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME SYSTEM; THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME REVEL SYSTEM; AND THE MINIMED 530G INSULIN PUMP IS A PART OF THE MINIMED 530G 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