BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    PMA: P160048 · Decision Jun 21, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Continuous Glucose Monitor, Implanted, Adjunctive Use
    Trade Name
    EVERSENSE CONTINUOUS GLUCOSE MONITORING SYSTEM
    PMA Number
    P160048
    Device Class
    FDA Class 3
    Product Code
    QCD
    Generic Name
    Continuous glucose monitor, implanted, adjunctive use
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 21, 2018
    Date Received
    October 26, 2016
    Expedited Review
    N
    Docket Number
    18M-2463

    Advisory Committee Statement

    Approval for The Eversense CGM System. The device is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 90 days.The system is intended to:1) Provide real-time glucose readings;2) Provide glucose trend information; and3) Provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia).The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time.The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QCD Continuous Glucose Monitor, Implanted, Adjunctive Use