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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 NameDEXCON G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP120005
Supplement NumberS017
Date Received04/03/2014
Decision Date05/02/2014
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change for the method of measurement of critical dimensions during receiving inspection of the dexcom g4 platinum transmitter tray, and the use of a food grade silicone spray during manufacturing of the transmitter tray.
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