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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 NumberS013
Date Received03/28/2016
Decision Date04/27/2016
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  
Change to incorporate a step that allows the operators to wipe excess Glucose Oxidase (GOx) material from the plate during Enlite glucose sensor manufacturing. The Enlite glucose sensor is a component of the MiniMed 530G System, and the Paradigm REAL-Time REVEL System with Enlite Sensor.
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