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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S082 · Decision Jan 27, 2016
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    ARTIFICIAL PANCREAS DEVICE SYSTEM, THRESHOLD SUSPEND
    PMA Number
    P120010
    Supplement Number
    S082
    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 27, 2016
    Date Received
    December 28, 2015
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    THE APPROVAL OF A TRANSITION OF THE MANUFACTURING OF THE TYVEK LIDS USED FOR PACKAGING THE ENLITE SENSOR COMPONENT FROM THE SUPPLIER'S FACILITY IN PHILADELPHIA TO OSHKOSH, WISCONSIN. ADDITIONALLY, THE FACILITY TRANSITION INCLUDES NEW MANUFACTURING ASSETS INCLUDING COATER AND DIE CUT LID PRESS. THE ENLITE SENSOR IS A COMPONENT OF THE 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