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

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S170 · Decision Dec 3, 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 PUMPS
    PMA Number
    P980022
    Supplement Number
    S170
    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 3, 2014
    Date Received
    November 3, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE TO A REJECTION CRITERION IN THE HARVEST OF USED MOTORS DURING THEMANUFACTURING OF REFURBISHED PUMPS. THE MOTOR IS A PART OF THE INSULIN PUMP IN THE PARADIGMREAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), THE PARADIGM REALTIMEREVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), AND THE MINIMED 530G SYSTEM (MMT-551, MMT-751).

    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