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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 NameDEXCOM SEVEN PLUS SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS048
Date Received07/05/2012
Decision Date08/03/2012
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 
Addition of an alternative component supplier. Actimed, for the pushrod and cannula components of the sensor applicator of the device.
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