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

    Automated Insulin Dosing Device System, Single Hormonal Control

    PMA: P160017 · Supplement: S019 · Decision Oct 11, 2017
    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 67G Insulin Pump
    PMA Number
    P160017
    Supplement Number
    S019
    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
    October 11, 2017
    Date Received
    September 14, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    New manufacturing process to allow printed circuit board assemblies to be harvested and re-used for construction of refurbished and loaner 630G and 670G insulin pumps. The 630G and 670G insulin pumps are components of the MiniMed 630G and MiniMed 670G systems, respectively.

    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