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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 PUMPS
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS170
Date Received11/03/2014
Decision Date12/03/2014
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE TO A REJECTION CRITERION IN THE HARVEST OF USED MOTORS DURING THEMANUFACTURING OF REFURBISHED PUMPS. THE MOTOR IS A PART OF THE INSULIN PUMP IN THE PARADIGMREAL-TIME SYSTEM (MMT-522, MMT-722, MMT-522K, MMT-722K), THE PARADIGM REALTIMEREVEL SYSTEM (MMT-523, MMT-723, MMT-523K, MMT-723K), AND THE MINIMED 530G SYSTEM (MMT-551, MMT-751).
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