BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S023 · Decision Oct 2, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    18
    Registration Numbers
    18

    Basic Information

    Device Name
    Automated Insulin Dosing , Threshold Suspend
    Trade Name
    MINILINK REAL-TIME TRANSMITTER
    PMA Number
    P120010
    Supplement Number
    S023
    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
    October 2, 2014
    Date Received
    April 29, 2014
    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 A CHANGE TO REPLACE THE CURRENT HOLDER (BLUE TEST PLUG)USED AS A PRODUCTION AID DURING SUB-ASSEMBLY MANUFACTURING OF THE MINILINK (MMT-7703) ANDIPRO2 (MMT-7741) TRANSMITTERS TO TWO NEW HOLDERS. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, GUARDIAN REAL-TIME, MINILINKREAL-TIME AND MINIMED 530G SYSTEMS. THE IPRO2 TRANSMITTER IS A COMPONENT OF THE IPRO2 PROFESSIONAL CONTINUOUS GLUCOSE MONITORING SYSTEM.

    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