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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 NumberS146
Date Received11/08/2013
Decision Date11/23/2015
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES IN THE WELDING PROCESS OF THE CLEAR PLASTIC WINDOW TO THE PUMP CASE OF THE PARADIGM REAL-TIME INSULIN PUMP (MODELS: MMT-522, MMT-522K), THE PARADIGM REAL-TIME REVEL INSULIN PUMP (MODELS: MMT-523, MMT-523K) AND THE MINIMED 530G INSULIN PUMP (MODEL: MMT-551). THE PARADIGM REAL-TIME INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME SYSTEM; THE PARADIGM REAL-TIME REVEL INSULIN PUMP IS A PART OF THE PARADIGM REAL-TIME REVEL SYSTEM; AND THE MINIMED 530G INSULIN PUMP IS A PART OF THE MINIMED 530G SYSTEM.
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