BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S177 · Decision Jan 22, 2016
    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
    S177
    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
    January 22, 2016
    Date Received
    December 30, 2014
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF AN ANNEALING PROCESS AND CHEMICAL EXPOSURE DURABILITY TEST FOR THE SMOKE COLOR IN THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMPS (MMT-753, MMT-753K) AND MINIMED 530G INSULIN PUMPS (MMT-751). THESE ARE COMPONENTS OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL AND MINIMED 530G SYSTEMS, 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