BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    PMA: P160048 · Supplement: S007 · Decision Jan 15, 2019
    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
    PMA Number
    P160048
    Supplement Number
    S007
    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
    January 15, 2019
    Date Received
    November 28, 2018
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for modification to the approved post-approval study protocol to include nurse practitioners and physicians assistants, in addition to physicians, as practitioners who will perform sensor insertions and removals.

    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