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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 & SEVEN PLUS SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS043
Date Received12/21/2011
Decision Date01/18/2012
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 
Change in a manufacturing fixture used in the attachment of an adhesive patch in the sensor/ applicator delivery system component in the seven and seven plus continuous glucose monitoring systems. Additionally, the mechanical instron pull test was replaced with a manual adhesive patch pull test to be used in receiving inspection for the disposable housing of the seven and seven plus continuous glucose monitoring systems.
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