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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S135 · Decision Nov 4, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    Medtronic MiniMed 530G System
    PMA Number
    P120010
    Supplement Number
    S135
    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
    November 4, 2019
    Date Received
    October 11, 2019
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Packaging, labeling, and final release activities of the One-Press Serter conducted at Medtronic, Inc. to be moved to contract manufacturer facility. The One-Press Serter is a component of the 530G System, the 630G System, the 670G System, and the Guardian Connect 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