BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S078 · Decision Oct 4, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    G4 PLATINUM Continuous Glucose Monitoring System and G5 Mobile Continuous Glucose Monitoring System
    PMA Number
    P120005
    Supplement Number
    S078
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 4, 2018
    Date Received
    September 7, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Extending the relative humidity excursion period for the Dexcom G4 PLATINUM/G5 Mobile Sensor. The proposed change seeks to extend the allowable relative humidity excursion period for the sensor component in its primary packaging. The Dexcom G4 PLATINUM/G5 Mobile Sensor is a component of the Dexcom G4 Platinum and Dexcom G5 Mobile Continuous Glucose Monitoring System, respectively.

    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