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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.
 
DeviceDEXCOM SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
Applicant
DEXCOM, INC.
5555 oberlin dr
san diego, CA 92121
PMA NumberP050012
Supplement NumberS052
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/material
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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