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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameDEXCON SEVEN SENSOR
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS021
Date Received11/05/2009
Decision Date12/04/2009
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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