BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    PMA: P160048 · Supplement: S002 · Decision Nov 6, 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 (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
    PMA Number
    P160048
    Supplement Number
    S002
    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
    November 6, 2018
    Date Received
    August 7, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modifying the instructions for use of the Eversense Continuous Glucose Monitoring System to specify that, in addition to physicians, nurse practitioners and physicians assistants who have completed the required training may insert and remove the Eversense sensor.

    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