BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S021 · Decision Apr 18, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    PARADIGM REAL-TIME SYSTEM AND GUARDIAN REAL-TIME SYSTEM
    PMA Number
    P980022
    Supplement Number
    S021
    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
    April 18, 2008
    Date Received
    October 24, 2007
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR AN OPTIONAL CAPABILITY OF AUTOMATICALLY DOWNLOADING GLUCOSE RESULTS FROM THE LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER IN ADDITION TO THE CURRENT BD PARADIGM LINK GLUCOSE METER. THIS MODIFICATION INCLUDES AN OPTIONAL CAPABILITY FOR THE MINIMED PARADIGM REAL-TIME INSULIN INFUSION PUMPS OR THE GUARDIAN REAL-TIME GLUCOSE MONITOR TO RECEIVE BLOOD GLUCOSE VALUES AUTOMATICALLY TRANSMITTED BY A LIFESCAN ONETOUCH ULTRALINK BLOOD GLUCOSE METER. THE GUARDIAN? REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, IN CHILDREN AND ADULTS, AGES 7 AND UP, WITH DIABETES MELLITUS, FOR THE PURPOSE OF IMPROVING DIABETES MANAGEMENT. IT ALERTS IF A GLUCOSE LEVEL FALLS BELOW, OR RISES ABOVE, PRESET VALUES. VALUES ARE NOT INTENDED TO BE USED DIRECTLY FOR MAKING THERAPY ADJUSTMENTS, BUT RATHER TO PROVIDE AN INDICATION OF WHEN A FINGERSTICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE MONITOR. THE SYSTEM PROVIDES REAL-TIME GLUCOSE VALUES THAT ALLOW USERS TO TRACK PATTERNS IN GLUCOSE CONCENTRATIONS AND TO POSSIBLY IDENTIFY EPISODES OF LOW AND HIGH BLOOD GLUCOSE. IT ALSO STORES THE DATA SO THAT IT CAN BE ANALYZED TO TRACK PATTERNS. GLUCOSE DATA CAN BE FURTHER DOWNLOADED TO PC SOFTWARE FOR ANALYSIS OF HISTORICAL GLUCOSE VALUES. THE GUARDIAN REAL-TIME MONITOR CAN BE PROGRAMMED TO RECEIVE FINGERSTICK BLOOD GLUCOSE CALIBRATION VALUES TRANSMITTED FROM THE BD PARADIGM LINK OR LIFESCAN ONETOUCH ULTRALINK GLUCOSE METERS. CALIBRATION VALUES FROM OTHER GLUCOSE METERS MUST BE MANUALLY ENTERED INTO THE MONITOR. THE PARADIGM? REAL-TIME SYSTEM IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, AND POSSIBLE LOW AND HIGH BLOOD GLUCOSE EPISODES IN CHILDREN AND ADULTS, AGES 7 AND UP....(SEE APPROVAL ORDER FOR ADDITIONAL INFO)

    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