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U.S. Department of Health and Human Services

Devices@FDA
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Note: if a medical device has supplements, the device description and instructions may have
changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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61 supplements returned for P150019

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
paradigm™ real-time revel™ system

supplement #: S064
Medtronic Minimed Dec 17, 2021 labeling change - indications/instructions/shelf life/tradename  
enlite sensor (mmt-7008)

supplement #: S065
Medtronic Minimed Apr 29, 2022 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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