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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePARADIGM REAL-TIME REVEL INSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS089
Date Received10/04/2010
Decision Date10/13/2010
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE TRADE NAME CHANGE FOR PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS MMT-523, MMT-723, MMT-523K, MMT-723K). THE NEW TRADE NAME FOR THESE INSULIN PUMPS IS PARADIGM REAL-TIME REVEL INSULIN PUMP.
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