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

    Automated Insulin Dosing , Threshold Suspend

    PMA: P120010 · Supplement: S045 · Decision Dec 4, 2014
    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
    PMA Number
    P120010
    Supplement Number
    S045
    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 4, 2014
    Date Received
    November 4, 2014
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    IMPLEMENTATION OF FIVE ADDITIONAL PIECES OF EQUIPMENT AT A CONTRACT MANUFACTURER TO SUPPORT THE MANUFACTURE OF THE LITHIUM POLYMER BATTERIES FOR THE MINILINKREAL-TIME TRANSMITTER MODEL NUMBER MMT-7703 AND THE IPRO2 DIGITAL RECORDER MODEL NUMBER MMT-7741. THE MINILINK TRANSMITTER IS A COMPONENT OF THE PARADIGM REAL?] TIME SYSTEM, PARADIGM REAL?] TIME REVEL SYSTEM, GUARDIAN REAL?]TIME SYSTEM, MINILINKREAL?]TIME SYSTEM, AS WELL AS THE MINIMED 530G SYSTEM. THE IPRO2 RECORDER 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