BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P160030 · Supplement: S042 · Decision May 21, 2020
    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
    S042
    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
    May 21, 2020
    Date Received
    April 1, 2020
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Location Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a manufacturing site located at Tech Group Europe Limited t/a West, Damastown Close, Damastown Industrial Park, Mulhuddart, Dublin 15, D15 K009 Ireland for sensor kit assembly. The sensor kit is a component of the Freestyle Libre 14 day 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