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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 NumberS014
Date Received12/06/2013
Decision Date03/05/2014
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason change design/components/specifications - specifications
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the dexcom studio software: support was added for windows 8, open office, and canadian english and canadian french installations; improved system performance for large clinics that manage large numbers of patients; the word blinded was added to every chart when the receiver data is downloaded in blinded mode; the tooltip was translated into various languages; and labeling changes were made to the dexcom studio software guide, g4 sensor manual, and receiver replacement guide.
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