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U.S. Department of Health and Human Services

Devices@FDA
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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™ System
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150019
Supplement NumberS064
Date Received11/17/2021
Decision Date12/17/2021
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01464346
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for a labeling update to provide additional clarity on an existing warning for acetaminophen interference to the continuous glucose monitoring (CGM) component of the system.
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