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U.S. Department of Health and Human Services

Devices@FDA
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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 SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
5555 Oberlin Dr.
San Diego, CA 92121
PMA NumberP050012
Supplement NumberS052
Date Received12/06/2013
Decision Date03/05/2014
Withdrawal Date08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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