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U.S. Department of Health and Human Services

Devices@FDA
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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.
 
DeviceMedtronic MiniMed iPro2 CGM System with Elite Sensor
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP150029
Supplement NumberS018
Date Received03/26/2018
Decision Date05/23/2018
Product Codes MDS OZO 
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
RecallsCDRH Recalls
Approval Order Statement  
Addition of contamination controls at a supplier during manufacturing of liquid glucose oxidase. The glucose oxidase is used in production of Enlite and Guardian glucose sensors.
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