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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 SEVEN SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS016
Date Received08/04/2008
Decision Date02/13/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Clinical Trials NCT00722241
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the receiver user interface and algorithm, and modifications to the transmitter to make it compatible to the modified receiver algorithm.
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