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DexCom, Inc. (DXCM) Message Board

  • anthonyroberts_lb anthonyroberts_lb May 22, 2011 9:53 AM Flag

    FDA aproval

    P050012/S036
    3/2/11

    DexCom Seven and Seven Plus Continuous Glucose Monitoring System

    DexCom Inc.
    San Diego, CA
    92121

    Alternate Vendor and method of manufacture of the disposable seal component of the applicator assembly of the Seven and Seven Plus systems. The proposed change applies only to the disposable seal supplier and the method of manufacture; neither the materials nor the final design of the disposable seal are altered. Sensor performance and release specification will also remain unchanged

 
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