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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 NamePARADIGM REAL-TIME REVEL INSULIN PUMP
Classification Namesensor, glucose, invasive
Applicant MEDTRONIC INC.
PMA NumberP980022
Supplement NumberS112
Date Received02/29/2012
Decision Date04/27/2012
Product Code
MDS[ Registered Establishments with MDS ]
Advisory Committee Clinical Chemistry
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modifications (version 2. 5a) and related labeling modifications for the paradigm real-time revel pump (models mmt-532, mmt-723, mmt-523k, mmt723k). The paradigm revel insulin pump is a component of the paradigm real-time revel system.
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