BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    PMA: P160048 · Supplement: S021 · Decision Mar 29, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    7
    Registration Numbers
    7

    Basic Information

    Device Name
    Sensor, Glucose, Implanted, Non-Adjunctive Use
    Trade Name
    Eversense® E3 Continuous Glucose Monitoring (CGM) System
    PMA Number
    P160048
    Supplement Number
    S021
    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
    March 29, 2023
    Date Received
    September 30, 2022
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N
    Docket Number
    23M-1261

    Advisory Committee Statement

    Approval for the Eversense® E3 Continuous Glucose Monitoring System for modifying the device to reduce the frequency of calibration.

    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