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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 INSLIN PUMP
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS175
Date Received12/15/2014
Decision Date01/14/2015
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  
A CHANGE IN TERTIARY SUPPLIERS AND METHOD FOR THE NICKEL AND GOLD PLATING PROCESS FOR THE KEYPAD FLEXIBLE CIRCUIT FOR THE PARADIGM REAL-TIME INSULIN PUMP (MMT-522, MMT-522K, MMT-722, MMT-722K), PARADIGM REAL-TIME REVEL INSULIN PUMP (MMT-523,MMT-523K, MMT-723, MMT-723K) AND MINIMED 530G INSULIN PUMP (MMT-551, MMT-751) THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM, THE PARADIGM REAL-TIME REVEL SYSTEM AND THE MINIMED 530G SYSTEM, RESPECTIVELY.
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