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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.
 
DeviceIPRO2 CGM RECORDER
Generic NameSensor, glucose, invasive
ApplicantMEDTRONIC MINIMED
18000 DEVONSHIRE ST
NORTHRIDGE, CA 91325
PMA NumberP980022
Supplement NumberS127
Date Received11/13/2012
Decision Date02/20/2013
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
Approval Order Statement  
APPROVAL FOR MANUFACTURING CHANGES TO THE IPRO2 RECORDER COMPONENT OF THE IPRO2 CONTINUOUS GLUCOSE MONITORING SYSTEM THAT AFFECT THE SERIAL AND MODEL NUMBER ASSIGNMENT TOOL AND THE ACCURACY TESTER DEVICE LEVEL TESTER SOFTWARE.
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