BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S049 · Decision Sep 16, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G5 MOBILE CONTIUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S049
    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
    September 16, 2016
    Date Received
    June 21, 2016
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for updates to the G5 Mobile iOS App Software and G5 Mobile Transmitter Firmware for Dexcom’s G5 Mobile Continuous Glucose Monitoring System. The App is being modified to: backfill data from the CGM if there are data gaps within the last 3 hours; include mute override settings, which allow users to hear alerts critical to safe and effective use of the device even when their smart device is muted or turned to a very low volume; and to correct software anomalies. The Transmitter Firmware is being modified to: transmit data for backfill in the App; improve efficiency of battery usage on the transmitter; expand transmitter database logging to include additional information; support internal engineering efforts; and to correct software anomalies.

    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