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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S039 · Decision Nov 26, 2014
    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
    S039
    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 26, 2014
    Date Received
    October 27, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    CHANGE FROM A MANUAL PROCESS TO A SEMI-AUTOMATED PROCESS FOR A TEST CARRIEDOUT DURING ACCEPTANCE TESTING OF THE PARADIGM® REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K); PARADIGM® REAL-TIME REVEL INSULIN PUMP (MODELS:MMT-523, MMT-523K, MMT-723, MMT-723K); MINIMED 530G INSULIN PUMP (MODELS:MMT-551, MMT-751) CASES. THE PARADIGM® REAL-TIME, PARADIGM® REAL-TIME REVEL, ANDMINIMED 530G INSULIN PUMPS ARE COMPONENTS OF THE PARADIGM® REAL-TIME SYSTEM,PARADIGM® REAL-TIME REVEL SYSTEM, AND MINIMED 530G SYSTEM, RESPECTIVELY.

    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