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

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

    PMA: P250012 · Supplement: S003 · Decision Sep 12, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    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
    S003
    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
    September 12, 2025
    Date Received
    August 19, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    a change to the patch bonding process of Simplera and Simplera Sync sensors. The Simplera Sensor is a component of the Simplera system. The Simplera Sync sensor is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G systems

    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