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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 NumberS004
Date Received02/17/2016
Decision Date03/16/2016
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  
Manufacturing change in the preparation of the Piezo component of the electronic stack assemblies within the Paradigm REAL-Time Revel insulin pumps; a new preparation fixture is being used to assemble the Piezo component. The Paradigm REAL-Time Revel insulin pump is a component of the Paradigm REAL-Time Revel System with Enlite Sensor.
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