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

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

    PMA: P160030 · Supplement: S051 · Decision Apr 28, 2022
    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
    S051
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 28, 2022
    Date Received
    April 1, 2022
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Update an analytical method used to evaluate a raw ingredient of the glucose sensor component and to introduce the evaluation process to an additional manufacturing site. The glucose sensor is a component of the FreeStyle Libre 14-Day and FreeStyle Libre Pro Glucose Monitoring 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