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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 SYSTEM,PARADIGM REAL-TIME REVEL SYSTEM
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP980022
Supplement NumberS186
Date Received11/09/2015
Decision Date12/09/2015
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
TO MAKE CHANGES IN THE INCOMING INSPECTION CRITERIA FOR THE BLUE TEST PLUG TO REMOVE THE INSPECTION OF 5 NON-CRITICAL DIMENSIONS. THE BLUE TEST PLUG IS INTENDED FOR USE WITH THE MINILINK TRANSMITTER (MMT-7703) AND IT IS AN ACCESSORY OF PARADIGM REAL-TIME, PARADIGM REAL-TIME REVEL, AND MINIMED 530G SYSTEMS.
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