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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
guardian connect system

supplement #: S046
Medtronic Minimed Dec 08, 2022 process change - manufacturer/sterilizer/packager/supplier  
simplera™ system

supplement #: S047
Medtronic Minimed Jul 24, 2024 change design/components/specifications/material Approval Order
Summary of Safety & Effectiveness
Labeling
guardian sensor 3

supplement #: S049
Medtronic Minimed Jan 03, 2024 process change - manufacturer/sterilizer/packager/supplier  
guardian sensor 3

supplement #: S050
Medtronic Minimed Jan 05, 2024 process change - manufacturer/sterilizer/packager/supplier  
guardian 4 sensor

supplement #: S051
Medtronic Minimed Jul 17, 2024 process change - manufacturer/sterilizer/packager/supplier  
simplera (tm) system

supplement #: S052
Medtronic Minimed Sep 17, 2024 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system

supplement #: S053
Medtronic Minimed Aug 25, 2025 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system

supplement #: S054
Medtronic Minimed Oct 09, 2025 location change - manufacturer/sterilizer/packager/supplier  
simplera system

supplement #: S055
Medtronic Minimed Sep 12, 2025 process change - manufacturer/sterilizer/packager/supplier  
guardian connect system simplera system

supplement #: S056
Medtronic Minimed Oct 16, 2025 process change - manufacturer/sterilizer/packager/supplier  
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