BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    PMA: P160048 · Supplement: S006 · Decision Jun 6, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Sensor, Glucose, Implanted, Non-Adjunctive Use
    Trade Name
    Eversense Continuous Glucose Monitoring System
    PMA Number
    P160048
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    QHJ
    Generic Name
    Sensor, glucose, implanted, non-adjunctive use
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    June 6, 2019
    Date Received
    November 26, 2018
    Supplement Type
    Panel Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N
    Docket Number
    19M-2753

    Advisory Committee Statement

    Approval for the Eversense CGM System. The device is indicated for continually measuring glucose levels in adults (age 18 and older) with diabetes for up to 90 days. The system is indicated for use to replace fingerstick blood glucose measurements for diabetes treatment decisions.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 intended for single patient use.

    Classifications

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

    Product Code Device Name
    QHJ Sensor, Glucose, Implanted, Non-Adjunctive Use