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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.
 
Trade NameDEXCOM STS SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS002
Date Received07/28/2006
Decision Date08/21/2006
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for design revisions to the accessory software program to enable it to be used for consumer use. The software program, as modified will be marketed under the trade name dexcom dm-consumer and is indicated for use by consumers to allow for the transfer of glucose data stored by the dexcom sts system into a personal computer.
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