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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 NumberS052
Date Received11/07/2018
Decision Date12/07/2018
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01464346
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Introduce an alternative probe module and manufacturing process for Enlite sensor encapsulation. The Enlite sensor is a component of the MiniMed 530G System, the MiniMed 630G System with SmartGuard, the MiniMed Paradigm Real-Time Revel System, and the MiniMed iPro2 CGM System with Enlite Sensor.
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