BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S014 · Decision Mar 5, 2014
    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
    S014
    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
    March 5, 2014
    Date Received
    December 6, 2013
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE FOLLOWING CHANGES TO THE DEXCOM STUDIO SOFTWARE: SUPPORT WAS ADDED FOR WINDOWS 8, OPEN OFFICE, AND CANADIAN ENGLISH AND CANADIAN FRENCH INSTALLATIONS; IMPROVED SYSTEM PERFORMANCE FOR LARGE CLINICS THAT MANAGE LARGE NUMBERS OF PATIENTS; THE WORD BLINDED WAS ADDED TO EVERY CHART WHEN THE RECEIVER DATA IS DOWNLOADED IN BLINDED MODE; THE TOOLTIP WAS TRANSLATED INTO VARIOUS LANGUAGES; AND LABELING CHANGES WERE MADE TO THE DEXCOM STUDIO SOFTWARE GUIDE, G4 SENSOR MANUAL, AND RECEIVER REPLACEMENT GUIDE.

    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