BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive, Non-Adjunctive

    PMA: P160007 · Supplement: S047 · Decision Jul 24, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9

    Basic Information

    Device Name
    Sensor, Glucose, Invasive, Non-Adjunctive
    Trade Name
    Simplera™ System
    PMA Number
    P160007
    Supplement Number
    S047
    Device Class
    FDA Class 3
    Product Code
    PQF
    Generic Name
    Sensor, glucose, invasive, non-adjunctive
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    July 24, 2024
    Date Received
    February 15, 2023
    Supplement Type
    Panel Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the Simplera system. The Simplera system is a real-time continuous glucose monitoring (CGM) system indicated for the management of diabetes in persons ages 18 years and older. The Simplera system does not require calibration and is designed to replace fingerstick blood glucose (BG) testing for diabetes treatment decisions, unless otherwise indicated. Interpretation of the Simplera system results should be based on the glucose trends and several sequential sensor readings over time.

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    PQF Sensor, Glucose, Invasive, Non-Adjunctive