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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.
 
DeviceDEXCON SEVEN SENSOR
Generic NameSensor, glucose, invasive
ApplicantDexcom, Inc.
5555 Oberlin Dr.
San Diego, CA 92121
PMA NumberP050012
Supplement NumberS021
Date Received11/05/2009
Decision Date12/04/2009
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  
REPLACEMENT OF PAPER-BASED LOT HISTORY RECORDS (LHRS) WITH ELECTRONIC LHRS. THE CHANGE IMPLEMENTS CAMSTAR MANUFACTURING EXECUTION SYSTEM (MES), AN ELECTRONIC CONTROL SYSTEM FOR MANAGING AND MONITORING WORK-IN PROCESS ON A MANUFACTURING FLOOR.
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