BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S005 · Decision Aug 14, 2013
    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
    S005
    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
    August 14, 2013
    Date Received
    May 20, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE G4 PLATINUM FIRMWARE FOR THE G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM TO INCLUDE CODE REVISIONS AND FIRMWARE CHANGES TO IMPROVE COMMUNICATIONS, UPDATES TO THE FLASH MEMORY AND THE USB, PLUS A SINGLE CHANGE TO A DOCUMENTATION REVISION IN THE SOFTWARE REQUIREMENTS SPECIFICATION BUT NO CHANGES TO THE CODE WERE PERFORMED.

    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