BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S017 · Decision Jun 14, 2006
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P980022
    Supplement Number
    S017
    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
    June 14, 2006
    Date Received
    April 10, 2006
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR MODIFICATIONS TO THE MONITOR AND TRANSMITTER OF THE PREVIOUSLY APPROVED GUARDIAN RT SYSTEM. THE REAL-TIME MONITOR HAS A LARGER LCD FOR EASE OF VIEWING FOR THE USER AND TO SUPPORT GRAPHICAL DISPLAY OF THE DATA. ALSO, IN THE REAL-TIME MONITOR, RF COMMUNICATION IS RECEIVED FROM THE TRANSMITTER AT 916.35 MHZ, WHICH IS THE IDENTICAL FREQUENCY USED IN THE PARADIGM MODEL MMT-515/715 INSULIN PUMPS (CLEARED UNDER K040676). IN ADDITION, THE METER READINGS FOR CALIBRATION CAN BE MANUALLY ENTERED, IDENTICAL TO THE GUARDIAN RT, OR AUTOMATICALLY, VIA TELEMETRY, WHEN USING THE PARADIGM LINK METER IN THE IDENTICAL SCHEME AS IN THE PREVIOUSLY CLEARED INSULIN PUMP. THE CALIBRATION ALGORITHM AND GLUCOSE VALUES REPORTED BY THE SYSTEM ARE IDENTICAL BETWEEN THE GUARDIAN RT SYSTEM AND THE GUARDIAN REAL-TIME SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM AND IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF GLUCOSE LEVELS IN THE FLUID UNDER THE SKIN, IN ADULTS (AGES 18 AND OLDER) 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 FINGER STICK MAY BE REQUIRED. ALL THERAPY ADJUSTMENTS SHOULD BE BASED ON MEASUREMENTS OBTAINED USING A HOME GLUCOSE METER AND NOT ON GUARDIAN REAL-TIME CGM SYSTEM VALUES. THE GUARDIAN REAL-TIME CGM 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 VALUES.

    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