BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S160 · Decision Oct 8, 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
    PMA Number
    P980022
    Supplement Number
    S160
    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
    October 8, 2014
    Date Received
    August 11, 2014
    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 A CHANGE TO A SUPPLIER¿S PRODUCTION LINE FOR A MOTOR PART OF THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-523K,MMT-723 AND MMT-723K) AND THE MINIMED 530G INSULIN PUMPS (MODELS MMT-551 AND MMT-751). THE INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, PARADIGM REAL-TIME REVEL CONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE MINIMED 530G SYSTEM RESPECTIVELY.

    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