BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Implanted, Non-Adjunctive Use

    PMA: P160048 · Supplement: S023 · Decision Mar 22, 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 System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert
    PMA Number
    P160048
    Supplement Number
    S023
    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 22, 2023
    Date Received
    February 22, 2023
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Postapproval Study Protocol
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the revised protocol for the post-approval study (PAS) protocol.

    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