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

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S044 · Decision Jan 13, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G4 PLATINUM CONTINUOUS MONITORING SYSTEM, DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S044
    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
    January 13, 2016
    Date Received
    December 17, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    TO ADD AN ADDITIONAL CONTRACT LABORATORY FOR PERFORMING BIOBURDEN AND STERILITY TESTING, WHICH IS USED TO SUPPORT OF STERILIZATION VALIDATION OF THE G5 MOBILE/G4 PLATINUM SENSOR. THE G5 MOBILE/G4 PLATINUM SENSOR IS A COMPONENT OF THE DEXCOM G4 PLATINUM AND THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE 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