BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System

    PMA: P250012 · Supplement: S002 · Decision Oct 9, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

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    Basic Information

    Device Name
    Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System
    Trade Name
    Guardian 4 Sensor
    PMA Number
    P250012
    Supplement Number
    S002
    Device Class
    FDA Class 3
    Product Code
    SFI
    Generic Name
    Sensor, Glucose, Invasive, Component of automated insulin delivery system
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 9, 2025
    Date Received
    August 15, 2025
    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 Minimed Kentucky Distribution Center (aka UPS Supply Chain Solutions), 1860 Outer Loop #326, Louisville, KY 40219, USA, FEI 3006759904, for repacking and labeling.

    Classifications

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

    Product Code Device Name
    SFI Sensor, Glucose, Invasive, Component Of Automated Insulin Delivery System