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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 AND SEVEN PLUS SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
5555 Oberlin Dr.
San Diego, CA 92121
PMA NumberP050012
Supplement NumberS039
Date Received08/15/2011
Decision Date07/24/2012
Withdrawal Date08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A PROPOSED CHANGE TO REMOVE REDUNDANT DESTRUCTIVE TESTING FOR BOND STRENGTH OF THREE APPLICATOR COMPONENTS (CANNULA CARRIER, PUSH ROD CARRIER, AND SENSOR NEEDLE CARRIER) OF THE DEVICES.
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