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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.
 
DevicePARADIGM REAL-TIME INSULIN PUMP, PARADIGM REAL-TIME REVEL INSULIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS183
Date Received11/03/2015
Decision Date06/03/2016
Product Codes MDS OYC 
Advisory Committee Clinical Chemistry
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changes to the pump case drive support cap assembly process and the automated adhesive dispensing process used in the pump case manufacturing process of the Paradigm family of insulin pumps (models 5xx and 7xx). Paradigm insulin pumps are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System and the MiniMed 530G System.
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