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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 G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP120005
Supplement NumberS019
Date Received04/16/2014
Decision Date07/11/2014
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change to the transmitter that combines the components from two printed circuit board assemblies (pcbas) into a single board transmitter (sbt) with one printed circuit board (pcb).
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