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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.
 
DeviceSensor-Enabled Pump System-Continuous Glucose Monitoring System
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150019
Supplement NumberS016
Date Received06/15/2016
Decision Date12/08/2016
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT01464346
Supplement Type135 Review Track For 30-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  
Approval for adding a Cell Operating System (COS) for partial manual assembly of Enlite Sensors at Medtronic Puerto Rico Operations Company (MPROC) facility. The implementation of a COS includes adding new equipment and relocating existing equipment within the existing Enlite sensor manual assembly line. The Enlite sensor is a component of the MiniMed 530G System and the Paradigm Real-Time Revel System with Enlite Sensor.
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