BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S129 · Decision Feb 11, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME PUMP, PARADIGM REAL TIME REVEL INSULIN PUMP
    PMA Number
    P980022
    Supplement Number
    S129
    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
    February 11, 2013
    Date Received
    November 15, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR SUBSTITUTING THE CURRENT PVC INSULATION MATERIAL OF THE VIBRATOR MOTOR WIRING OF THE PARADIGM REAL-TIME AND PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODEL NUMBERS: MMT-522, MMT-522K, MMT-523, MMT-523K, MMT-722, MMT-722K, MMT-723, AND MMT-723K) WITH HALOGEN-FREE MATERIAL.

    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