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

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

    PMA: P250012 · Supplement: S005 · Decision Dec 10, 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
    Simplera Sync Sensor; Guardian 4 Sensor
    PMA Number
    P250012
    Supplement Number
    S005
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    December 10, 2025
    Date Received
    November 14, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    addition of an alternate manufacturing site for the final assembly of the Guardian 4 Sensor. The Guardian 4 sensor is a component of the MiniMed 780G System

    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