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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.
 
DeviceDEXCON SEVEN AND SEVEN PLUS
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
DEXCOM, INC.
5555 oberlin dr
san diego, CA 92121
PMA NumberP050012
Supplement NumberS027
Date Received07/13/2010
Decision Date11/16/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a reduction in standoff as well as addition of shock mounting on the receiver unit of the device.
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