BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S055 · Decision Dec 9, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G4 PLATINUM CONTIUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S055
    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 9, 2016
    Date Received
    September 14, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for firmware modifications to the receiver component in the following Dexcom Continuous Glucose Monitoring Systems: G4 PLATINUM, G4 PLATINUM (Professional), G4 PLATINUM with Share, and G4 PLATINUM with Share for Pediatrics.

    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