BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S037 · Decision Sep 23, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S037
    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 23, 2015
    Date Received
    July 16, 2015
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING FIRMWARE MODIFICATIONS TO THE SHARE RECEIVER OF THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM: UPDATES TO PREVENT UNNECESSARY REBOOTS, IMPROVEMENTS OF SPEED OF USB TRANSFERS, PREVENTION OF LONG CHARGE TIMES, IMPROVEMENT OF CONNECTION RELIABILITY, IMPROVEMENT OF BATTERY LIFE, IMPROVEMENT OF BUTTON USABILITY, AND IMPROVEMENT OF UPGRADE PROCESS.

    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