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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 PUMPS, PARADIGM REAL TIME REVEL INSULINPUMPS, GUARDIAN REAL TIME MONITOR.
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS155
Date Received04/14/2014
Decision Date05/14/2014
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  
NEW TOOL TO BE USED IN THE PROCESS OF CURING THE VIBRATOR MOTOR TO THE VIBRATOR MOTOR HOUSING IN THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522,MMT-522K, MMT-722, MMT-722K), A COMPONENT OF THE PARADIGM REAL-TIME CONTINUOUSGLUCOSE MONITORING SYSTEM, THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K, MMT-723, MMT-723K), A COMPONENT OF THE PARADIGM REAL-TIME REVELCONTINUOUS GLUCOSE MONITORING SYSTEM, AND THE GUARDIAN REAL-TIME CONTINUOUS GLUCOSE MONITORING SYSTEM.
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