BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Continuous Glucose Monitor, Implanted, Adjunctive Use

    PMA: P160048 · Supplement: S009 · Decision Jun 26, 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
    S009
    Device Class
    FDA Class 3
    Product Code
    QCD
    Generic Name
    Continuous glucose monitor, implanted, adjunctive use
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    June 26, 2019
    Date Received
    May 28, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Increased load size for a previously approved sterilization method, as well as approval for a new sealing device for the sterile barrier of the sensor component of the Eversense 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