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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 NumberS112
Date Received02/24/2012
Decision Date04/27/2012
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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