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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P150001 · Supplement: S110 · Decision Oct 16, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    Medtronic MiniMed 630G System
    PMA Number
    P150001
    Supplement Number
    S110
    Device Class
    FDA Class 3
    Product Code
    OZO
    Generic Name
    Automated insulin dosing , threshold suspend
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    October 16, 2025
    Date Received
    September 19, 2025
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    addition of a new supplier for a critical component of the Guardian Sensor (3) and Guardian 4 Sensor. The Guardian Sensor (3) is a component of the MiniMed 670G, MiniMed 770G, and MiniMed 780G Systems, MiniMed 630G System with Smart Guard, and Guardian Connect Systems. 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
    OZO Automated Insulin Dosing , Threshold Suspend