BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated

    PMA: P160030 · Supplement: S047 · Decision Sep 1, 2021
    View on FDA
    Classifications
    1
    FEI Numbers
    12
    Registration Numbers
    12

    Basic Information

    Device Name
    Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated
    Trade Name
    FreeStyle Libre 14-Day Flash Glucose Monitoring System
    PMA Number
    P160030
    Supplement Number
    S047
    Device Class
    FDA Class 3
    Product Code
    PZE
    Generic Name
    Sensor, glucose, invasive, non-adjunctive, factory-calibrated, user-initiated
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    September 1, 2021
    Date Received
    February 23, 2021
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval of a change in the membrane layer polymer of the Libre Sensor. The Libre Sensor is a component of the FreeStyle Libre Pro Flash Glucose Monitoring System and Freestyle Libre Flash Glucose Monitoring System.

    Classifications

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

    Product Code Device Name
    PZE Sensor, Glucose, Invasive, Non-Adjunctive, Factory-Calibrated, User-Initiated