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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 Insulin Pump
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150019
Supplement NumberS046
Date Received07/16/2018
Decision Date08/14/2018
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  
Addition of a new testing station to conduct additional reliability testing for the pump case of the Paradigm Real-Time Insulin Pumps, Paradigm Real-Time Revel Pumps, and MiniMed 530G Insulin Pumps at the manufacturing facility, located at Juncos, Puerto Rico. These pumps are components of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and MiniMed 530G System, respectively.
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