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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceDEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
6340 sequence dr
san diego, CA 92121
PMA NumberP120005
Supplement NumberS025
Date Received06/26/2014
Decision Date07/24/2014
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
CHANGE IN THE MANUFACTURING PROCESS OF THE TRANSMITTER PACKAGING TRAY TO INCREASE MOLD CAPACITY AT THEIR SUPPLIER. THE TRANSMITTER IS A COMPONENT OF THE DEXCOM G4PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM.
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