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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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28 supplements returned for P160048

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Device Name Company Date Approved Supplement Reason Other Information
eversense® e3 continuous glucose monitoring (cgm) system

supplement #: S022
Senseonics, Incorporated Mar 30, 2023 change design/components/specifications/material  
eversense e3 continuous glucose monitoring system (cgm system) - entire system, eversense e3 sensor, eversense e3 insert

supplement #: S023
Senseonics, Incorporated Mar 22, 2023 postapproval study protocol  
eversense e3 cgm system

supplement #: S024
Senseonics, Incorporated May 10, 2023 process change - manufacturer/sterilizer/packager/supplier  
eversense e3 continuous glucose monitoring system (cgm system) - entire system, eversense e3 sensor, eversense e3 insert

supplement #: S025
Senseonics, Incorporated Jun 09, 2023 process change - manufacturer/sterilizer/packager/supplier  
eversense e3 continuous glucose monitoring system (cgm system) - entire system, eversense e3 sensor, eversense e3 insert

supplement #: S026
Senseonics, Incorporated Dec 05, 2023 location change - manufacturer/sterilizer/packager/supplier  
eversense e3 continuous glucose monitoring system (cgm system) - entire system, eversense e3 sensor, eversense e3 insert

supplement #: S027
Senseonics, Incorporated Feb 22, 2024 process change - manufacturer/sterilizer/packager/supplier  
eversense e3 continuous glucose monitoring system, eversense e3 sensor, eversense insertion tools, eversense smart trans

supplement #: S028
Senseonics, Incorporated Oct 23, 2024 process change - manufacturer/sterilizer/packager/supplier  
eversense continuous glucose monitoring system

supplement #: S029
Senseonics, Incorporated Mar 27, 2025 postapproval study protocol  
eversense® continuous glucose monitoring system

supplement #: S031
Senseonics, Incorporated Mar 19, 2026 postapproval study protocol  
  We welcome your comments and feedback about Devices@FDA.
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