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

    Sensor, Glucose, Invasive

    PMA: P150019 · Supplement: S054 · Decision Mar 11, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Paradigm real-Time Rvel System
    PMA Number
    P150019
    Supplement Number
    S054
    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
    March 11, 2019
    Date Received
    February 11, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Additional equipment for the production of Tyvek lid and thermoformed tray used for the packaging of Guardian (3) and Enlite sensors. The Guardian Sensor (3) is a component of of the Medtronic MiniMed 670G, MiniMed 630G with SmartGuard and Guardian Connect Systems and the Enlite Sensor is a component of the Medtronic MiniMed 530G, MiniMed 630G with SmartGuard, iPro2 and Paradigm REAL-Time Revel Systems.

    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