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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, GUARDIAN REAL-TIME MONITOR
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS172
Date Received11/05/2014
Decision Date12/05/2014
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
Approval Order Statement  
ADDITIONAL MANUFACTURING TESTING TO BE PERFORMED ON A PREVIOUSLY APPROVEDCOMPONENT USED IN THE MANUFACTURE OF THE PARADIGM REAL-TIME INSULIN PUMPS (MMT-522,MMT-522K, MMT-722, MMT-722K) AND THE PARADIGM REAL-TIME REVEL INSULIN PUMPS(MMT-523, MMT-523K, MMT-723, MMT-723K) THAT ARE PART OF THE PARADIGM REAL-TIME SYSTEM AND THE PARADIGM REAL-TIME REVEL SYSTEM RESPECTIVELY. THIS COMPONENT IS ALSO USED IN THE GUARDIAN REAL-TIME MONITOR (CSS7100, CS7100K) THAT IS PART OF THE GUARDIAN REALTIME SYSTEM.
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