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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 CONTINUOUS GLUCOSE MONITORING SYSTEM
Classification Namesensor, glucose, invasive
ApplicantDEXCOM, INC.
PMA NumberP050012
Supplement NumberS047
Date Received05/30/2012
Decision Date06/29/2012
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 
Manufacturing change to semi-automate the assembly and ultraviolet bonding process for the cannula carrier (mt9754-01), pushrod carrier (mt9755-01) and needle carrier (mt9576-02) assemblies used in the sensor applicator component of the device.
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