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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.
Classification Namesensor, glucose, invasive
Generic Namesensor, glucose, invasive
5555 oberlin dr
san diego, CA 92121
PMA NumberP050012
Supplement NumberS029
Date Received07/30/2010
Decision Date08/25/2010
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Change to reduce the hold time after adhesive is applied to attach the adhesive patch to the disposable housing for the seven and seven plus continuous glucose monitoring systems.