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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.
 
DeviceGuardian Connect System
Generic NameSensor, glucose, invasive
ApplicantMedtronic Minimed
18000 Devonshire St.
Northridge, CA 91325
PMA NumberP160007
Supplement NumberS001
Date Received03/26/2018
Decision Date05/23/2018
Product Code MDS 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02246582
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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