BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing Device System, Single Hormonal Control

    PMA: P160017 · Supplement: S102 · Decision Oct 17, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Automated Insulin Dosing Device System, Single Hormonal Control
    Trade Name
    Medtronic MiniMed 670G System, Medtronic MiniMed 770G System
    PMA Number
    P160017
    Supplement Number
    S102
    Device Class
    FDA Class 3
    Product Code
    OZP
    Generic Name
    Automated insulin dosing device system, single hormonal control
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 17, 2022
    Date Received
    September 14, 2022
    Supplement Type
    Special (Immediate Track)
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    Approval for a labeling update to ensure that users recognize the need to save after setting all basal rate settings on new and replacement MiniMed 630G and 670G Systems

    Classifications

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

    Product Code Device Name
    OZP Automated Insulin Dosing Device System, Single Hormonal Control