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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 STS SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
DEXCOM, INC.
5555 oberlin dr
san diego, CA 92121
PMA NumberP050012
Supplement NumberS008
Date Received03/01/2007
Decision Date03/15/2007
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 
Move of the final kitting and shipping processes for the sts system to a second facility.
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