BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S149 · Decision Dec 24, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME INSULIN PUMPS
    PMA Number
    P980022
    Supplement Number
    S149
    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
    December 24, 2013
    Date Received
    November 29, 2013
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A LABELING CHANGE TO THE ERRATA SHEET TO PROVIDE ADDITIONAL INFORMATION ABOUT POTENTIAL WATER DAMAGE TO THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS: MMT-522, MMT-522K, MMT-722 AND MMT-722K) AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS: MMT-523, MMT-523K, MMT-723 AND MMT-723K).

    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