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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 AND SEVEN PLUS SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS038
Date Received07/14/2011
Decision Date08/12/2011
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Removal of redundant deburring steps from the cleaning processes of the needle and cannula components of the seven and seven plus continuous glucose monitoring systems.
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