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

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S071 · Decision Mar 27, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    Dexcom G4 Platinum and G5 Mobile Continuous Glucose Monitoring Systems
    PMA Number
    P120005
    Supplement Number
    S071
    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
    March 27, 2018
    Date Received
    February 27, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Removal of redundant inspection of the skived wire component, which will be processed further to manufacture the finished sensor probes. The sensors are components of the Dexcom G4 PLATINUM and Dexcom G5 Mobile Continuous Monitoring Systems.

    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