BEUDAMED
    FDA PMA FDA Class 3 Approved (Withdrawn) 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P050020 · Decision Mar 12, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITOR
    PMA Number
    P050020
    Device Class
    FDA Class 3
    Product Code
    MDS
    Generic Name
    Sensor, glucose, invasive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    March 12, 2008
    Date Received
    June 8, 2005
    Expedited Review
    Y
    Docket Number
    08M-0207

    Advisory Committee Statement

    APPROVAL FOR THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM. THE DEVICE IS INDICATED FOR THE FOLLOWING: THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS INDICATED FOR CONTINUALLY RECORDING INTERSTITIAL FLUID GLUCOSE LEVELS IN PEOPLE (AGES 18 AND OLDER) WITH DIABETES MELLITUS FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. READINGS AND ALARMS ABOUT GLUCOSE LEVELS FROM THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM ARE NOT INTENDED TO REPLACE TRADITIONAL BLOOD GLUCOSE MONITORING. BEFORE ADJUSTING THERAPY FOR DIABETES MANAGEMENT BASED ON THE RESULTS AND ALARMS FROM THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM, TRADITIONAL BLOOD GLUCOSE TESTS MUST BE PERFORMED. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM PROVIDES A BUILT-IN BLOOD GLUCOSE METER TO CONFIRM THE CONTINUOUS GLUCOSE RESULT. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM PROVIDES REAL-TIME READINGS, GRAPHS, TRENDS AND GLUCOSE ALARMS DIRECTLY TO THE USER. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS INTENDED TO BE USED IN HOME SETTINGS TO AID PEOPLE WITH DIABETES IN PREDICTING AND DETECTING EPISODES OF HYPOGLYCEMIA AND HYPERGLYCEMIA AND IN CLINICAL SETTINGS TO AID HEALTHCARE PROFESSIONALS IN EVALUATING GLUCOSE CONTROL. THE FREESTYLE NAVIGATOR CONTINUOUS GLUCOSE MONITORING SYSTEM IS AVAILABLE ONLY BY PRESCRIPTION.

    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