BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P120005 · Supplement: S033 · Decision Aug 19, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P120005
    Supplement Number
    S033
    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 19, 2015
    Date Received
    February 25, 2015
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR CHANGES TO THE DEXCOM TRANSMITTER AND RECEIVER AND THE ADDITION OF THE DEXCOM G5 MOBILE APP, TO ENABLE THE TRANSMISSION OF CGM DATA TO THE RECEIVER AND/OR COMPATIBLE APPLE MOBILE DEVICES, AND TO ALLOW ENTRY OF SYSTEM CALIBRATION INFORMATION DIRECTLY FROM COMPATIBLE APPLE MOBILE DEVICES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED AS FOLLOWS:THE DEXCOM G5 MOBILE CONTINUOUS GLUCOSE MONITORING SYSTEM IS A GLUCOSE MONITORING SYSTEM INDICATED FOR DETECTING TRENDS AND TRACKING PATTERNS IN PERSONS (AGE 2 AND OLDER) WITH DIABETES. THE SYSTEM IS INTENDED FOR SINGLE PATIENT USE AND REQUIRES A PRESCRIPTION. THE DEXCOM G5 MOBILE SYSTEM IS INDICATED FOR USE AS AN ADJUNCTIVE DEVICE TO COMPLEMENT, NOT REPLACE, INFORMATION OBTAINED FROM STANDARD HOME GLUCOSE MONITORING DEVICES. THE DEXCOM G5 MOBILE SYSTEM AIDS IN THE DETECTION OF EPISODES OF HYPERGLYCEMIA AND HYPOGLYCEMIA, FACILITATING BOTH ACUTE AND LONG-TERM THERAPY ADJUSTMENTS, WHICH MAY MINIMIZE THESE EXCURSIONS. INTERPRETATION OF THE DEXCOM G5 MOBILE SYSTEM RESULTS SHOULD BE BASED ON THE TRENDS AND PATTERNS SEEN WITH SEVERAL SEQUENTIAL READINGS OVER TIME.

    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