BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

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

    PMA: P250012 · Decision Aug 6, 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
    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
    August 6, 2025
    Date Received
    April 18, 2025
    Expedited Review
    N

    Advisory Committee Statement

    Approval of the Simplera Sync sensor and Guardian 4 sensor, intended to function as components of a Medtronic automated insulin dosing 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