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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceDEXCOM SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
DEXCOM, INC.
5555 oberlin dr
san diego, CA 92121
PMA NumberP050012
Supplement NumberS036
Date Received01/31/2011
Decision Date03/02/2011
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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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