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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 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 & SEVEN PLUS SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDEXCOM, INC.
5555 OBERLIN DR
SAN DIEGO, CA 92121
PMA NumberP050012
Supplement NumberS029
Date Received07/30/2010
Decision Date08/25/2010
Withdrawal Date 08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
CHANGE TO REDUCE THE HOLD TIME AFTER ADHESIVE IS APPLIED TO ATTACH THE ADHESIVE PATCH TO THE DISPOSABLE HOUSING FOR THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.
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