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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-Tme Revel System
Generic Namesensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 devonshire st
northridge, CA 91325
PMA NumberP150019
Supplement NumberS060
Date Received10/17/2019
Decision Date11/15/2019
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  
Supplier of the Glucose Oxidase used in the fabrication of the Enlite Sensor and Guardian Sensor (3) moved their manufacturing facility from one location to another within the United Kingdom.
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