BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    PMA: P160048 · Supplement: S026 · Decision Dec 5, 2023
    View on FDA
    Classifications
    1
    FEI Numbers
    8
    Registration Numbers
    8

    Basic Information

    Device Name
    Continuous Glucose Monitor, Implanted, Adjunctive Use
    Trade Name
    Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
    PMA Number
    P160048
    Supplement Number
    S026
    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
    December 5, 2023
    Date Received
    August 11, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at RR Donnelley - Supply Chain Solutions, 1600 Disk Dr., Plover, WI 54467-3131, to perform kitting of the final components, labeling, storage, and distribution of the Eversense E3 CGM System.

    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