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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 NumberS134
Date Received04/10/2013
Decision Date07/08/2013
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES TO THE PARADIGM REAL-TIME REVELINSULIN PUMP (MMT-523, MMT-523K, MMT-723, AND MMT-723K) APPLICATION SOFTWARE. THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A COMPONENT OF THE PARADIGM REAL-TIME REVEL SYSTEM.
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