BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Supplement: S010 · Decision Jan 7, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS)
    PMA Number
    P980022
    Supplement Number
    S010
    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
    January 7, 2004
    Date Received
    November 29, 2002
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    12M-0965

    Advisory Committee Statement

    APPROVAL FOR THE GUARDIAN TELEMETERED GLUCOSE MONITORING SYSTEM (TGMS). THE DEVICE IS INDICATED FOR CONTINUOUS OR PERIODIC MONITORING OF INTERSTITIAL GLUCOSE VALUES IN PERSONS WITH DIABETES MELLITUS. GLUCOSE VALUES CALCULATED BY THE DEVICE WILL BE USED TO TRIGGER HYPO- AND HYPERGLYCEMIA ALERTS BUT GLUCOSE VALUES WILL NOT BE DISPLAYED. UP TO 21 DAYS OF STORED DATA CAN BE DOWNLOADED TO A PERSONAL COMPUTER TO IDENTIFY PATTERNS AND OPTIMIZE DIABETES MANAGEMENT.

    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