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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
18000 devonshire st
northridge, CA 91325
PMA NumberP980022
Supplement NumberS110
Date Received02/09/2012
Decision Date07/17/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for language and pictorial changes to the instructions foruse (ifu) of the sof-sensor glucose sensor (mmt-7002) to make it consistent with the language that is included in the currently approved paradigm real-time revel insulin pump and paradigm real-time insulin pump user guides. The sof-sensor, paradigm real-time revel insulin pump and paradigm real-time insulin pump are components of the paradigm real- time system, guardian real-time system, and ipro2 professional continuous glucosemonitoring (cgm) system.