BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S005 · Decision Aug 21, 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
    S005
    Device Class
    FDA Class 3
    Product Code
    OZO
    Generic Name
    Automated insulin dosing , threshold suspend
    Medical Specialty
    Unknown
    Advisory Committee
    Clinical Chemistry
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 21, 2014
    Date Received
    November 8, 2013
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE IMPLEMENTATION OF A PNEUMATIC PRESS TOOL IN PLACEOF A MANUAL PRESS TOOL IN THE MANUFACTURING PROCESS OF THE PARADIGM REAL-TIME INSULIN PUMP(MODELS:MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVELINSULIN-PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), GUARDIAN REALTIMEMONITOR (MODELS: CSS7100 AND CSS17100K) AND THE MINIMED 530G INSULIN PUMP(MODELS: MMT-551 AND MMT-751). THESE PARTS ARE COMPONENTS OF THE PARADIGM REAL-TIMESYSTEM, PARADIGM REAL-TIME REVEL SYSTEM, GUARDIAN REAL-TIME CONTINUOUS GLUCOSEMONITORING SYSTEMS AND THE 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