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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S078 · Decision Dec 8, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    MINIMED 530G INSULIN PUMP
    PMA Number
    P120010
    Supplement Number
    S078
    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
    December 8, 2015
    Date Received
    November 9, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE APPROVAL OF A MANUFACTURING CHANGE REGARDING THE PREPARATION OF THE PIEZO COMPONENT OF THE ELECTRONIC STACK ASSEMBLIES WITH THE PARADIGM REAL-TIME/REAL-TIME REVEL AND 530G SYSTEM PUMPS; A NEW PREPARATION FIXTURE IS BEING USED TO ASSEMBLE THE PIEZO COMPONENT. THE AFFECTED INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM REAL-TIME/REAL-TIME REVEL SYSTEMS AND MINIMED 530G 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