BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160030 · Supplement: S010 · Decision Oct 31, 2018
    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 Flash Glucose Monitoring System; FreeStyle Libre 14 Day Flash Glucose Monitoring System
    PMA Number
    P160030
    Supplement Number
    S010
    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
    October 31, 2018
    Date Received
    February 26, 2018
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for the addition of the FreeStyle LibreLink App (iOS) as a compatible reading device and alternative primary display for the FreeStyle Libre and Freestyle Libre 14 Day Systems.

    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