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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 NumberS203
Date Received01/29/2018
Decision Date02/28/2018
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Changes to the test method for the bolus accuracy and timing test that is performed for the insulin pump component of the Paradigm Real-time system, Paradigm Real-Time REVEL system, MiniMed 530G system, MiniMed 630G system, and MiniMed 670G system.
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