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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 & SEVEN PLUS SYSTEM
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
5555 Oberlin Dr.
San Diego, CA 92121
PMA NumberP050012
Supplement NumberS043
Date Received12/21/2011
Decision Date01/18/2012
Withdrawal Date08/28/2015
Product Code MDS 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN A MANUFACTURING FIXTURE USED IN THE ATTACHMENT OF AN ADHESIVE PATCH IN THE SENSOR/APPLICATOR DELIVERY SYSTEM COMPONENT IN THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS. ADDITIONALLY, THE MECHANICAL INSTRON PULL TEST WAS REPLACED WITH A MANUAL ADHESIVE PATCH PULL TEST TO BE USED IN RECEIVING INSPECTION FOR THE DISPOSABLE HOUSING OF THE SEVEN AND SEVEN PLUS CONTINUOUS GLUCOSE MONITORING SYSTEMS.
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