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

    Automated Insulin Dosing Device System, Single Hormonal Control

    PMA: P160017 · Supplement: S036 · Decision Mar 9, 2018
    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
    MiniMed 670G System
    PMA Number
    P160017
    Supplement Number
    S036
    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
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    March 9, 2018
    Date Received
    February 7, 2018
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adding a new press, two new molds and a new quality control measurement system at the contract manufacturer. The changes will apply to the Enlite Sensor and Guardian Sensor (3) which are part of the MiniMed 530G, MiniMed 630G, Paradigm Real-Time Revel, iPro2 CGM, and Medtronic 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