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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCONTINUOUS GLUCOSE MONITORING SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS190
Date Received03/07/2016
Decision Date04/05/2016
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Relocation of a contract manufacturing facility for printed circuit boards and board stack assemblies used in all Medtronic MiniMed Paradigm Real-Time Revel insulin pumps, Paradigm Real-Time insulin pumps, and MiniMed 530G insulin pumps. The firm is also requesting changes in the manufacturing process sequence as well as updates to mechanical drawings to add vendor name and pump models. The Paradigm Real-Time insulin pumps are a component of the Paradigm Real-Time System, Paradigm Real-Time Revel System, and the Paradigm Real-Time Revel System with Enlite Sensor. The MiniMed 530G insulin pumps are a component of the MiniMed 530G System.
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