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

    Sensor, Glucose, Invasive

    PMA: P150029 · Supplement: S023 · Decision Nov 30, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    MiniMed iPro2 CGM System with Enlite Sensor
    PMA Number
    P150029
    Supplement Number
    S023
    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
    November 30, 2018
    Date Received
    November 2, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New glucose analyzers to be used for in-process testing and lot release activities for the Enlite and Guardian Sensor 3 continuous glucose monitoring sensors. These sensors are components of the MiniMed Paradigm Real-Time Revel, iPro2, 530G, 630G, 670G, and Guardian Connect 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