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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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54 supplements returned for P160007

New Search  Back to Search Results | Help
Device Name Company Date Approved Supplement Reason Other Information
simplera system

supplement #: S057
Medtronic Minimed Dec 05, 2025 process change - manufacturer/sterilizer/packager/supplier  
minimed go app; simplera sensor

supplement #: S058
Medtronic Minimed Jan 23, 2026 change design/components/specifications/material  
simplera system

supplement #: S059
Medtronic Minimed Dec 08, 2025 process change - manufacturer/sterilizer/packager/supplier  
simplera system

supplement #: S060
Medtronic Minimed Jun 12, 2026 change design/components/specifications/material  
simplera and simplera sync

supplement #: S062
Medtronic Minimed May 26, 2026 process change - manufacturer/sterilizer/packager/supplier  
  We welcome your comments and feedback about Devices@FDA.
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