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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P150001 · Supplement: S032 · Decision Jan 19, 2018
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    Medtronic MiniMed 630G System
    PMA Number
    P150001
    Supplement Number
    S032
    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
    January 19, 2018
    Date Received
    December 22, 2017
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    Adding a new ISO Class 8 Cleanroom for the manufacturing of Enlite Sensors and Guardian Sensors at Medtronics Northridge facility. The Enlite sensors are components of the MiniMed 530G, Paradigm Real-Time Revel, and iPro2 CGM systems and the Guardian Sensors are components of the MiniMed 630G and MiniMed 670G systems.

    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