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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 SHORT TERM GLUCOSE SENSOR (STS)
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
DEXCOM, INC.
5555 oberlin dr
san diego, CA 92121
PMA NumberP050012
Supplement NumberS004
Date Received09/07/2006
Decision Date09/22/2006
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 
Modification of the application process to one of the layers in te multi-layer membrane system.
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