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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 NumberS032
Date Received08/04/2010
Decision Date08/25/2010
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 ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO THE MANUFACTURE OF THE DEXCOM SEVEN AND SEVEN PLUS SYSTEM RECEIVER TO IMPROVE THE MANUFACTURING CONSISTENCY OF THE RECEIVER COMPONENT OF THE DEVICE.
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