BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive

    PMA: P980022 · Decision Jun 15, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    23
    Registration Numbers
    23

    Basic Information

    Device Name
    Sensor, Glucose, Invasive
    Trade Name
    CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P980022
    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 15, 1999
    Date Received
    December 15, 1997
    Expedited Review
    Y
    Docket Number
    99M-2169

    Advisory Committee Statement

    The device is intended to continuously record interstitial glucose levels in persons with diabetes mellitus. This information is intended to supplement, not replace blood glucose information obtained using standard home glucose monitoring devices. The information collected by the device may be downloaded and displayed on a computer and review by healthcare professionals. This information may allow identification of patterns of glucose level excursions above or below the desired range, facilitating therapy adjustments, which may minimize these excursions.

    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