BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S116 · Decision May 24, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PRARDIGM REAL-TIME INSULIN PUMPS AND GUARDIAN REAL-TIME MONITOR
    PMA Number
    P980022
    Supplement Number
    S116
    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
    May 24, 2012
    Date Received
    March 26, 2012
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL OF A CHANGE OF THE FIELD EFFECT TRANSISTOR (FET), A COMPONENTOF THE PARADIGM REAL-TIME REVEL INSULIN PUMPS (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K), THE PARADIGM REAL-TIME INSULIN PUMPS (MODELS MMT-522, MMT-722, MMT-522K, MMT-722K), AND THE GUARDIAN REAL-TIME MONITOR (MODELS CSS7100 AND CSS7100K), WHICH ARE COMPONENTS OF THE PARADIGM REAL-TIME AND GUARDIAN REAL-TIME 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