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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 continuous glucose monitoring system

supplement #: S010
Senseonics, Incorporated Jul 24, 2019 process change - manufacturer/sterilizer/packager/supplier  
eversense continuous glucose monitoring system

supplement #: S011
Senseonics, Incorporated Aug 29, 2019 change design/components/specifications/material  
eversense continuous glucose monitoring system

supplement #: S012
Senseonics, Incorporated Nov 25, 2019 postapproval study protocol  
eversense continuous glucose monitoring system

supplement #: S013
Senseonics, Incorporated Aug 29, 2019 process change - manufacturer/sterilizer/packager/supplier  
eversense continuous glucose monitoring system

supplement #: S014
Senseonics, Incorporated Oct 29, 2019 location change - manufacturer/sterilizer/packager/supplier  
eversense® e3 continuous glucose monitoring system

supplement #: S016
Senseonics, Incorporated Feb 10, 2022 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
eversense continuous glucose monitoring system

supplement #: S017
Senseonics, Incorporated Dec 11, 2020 process change - manufacturer/sterilizer/packager/supplier  
eversense e3 continuous glucose monitoring system

supplement #: S018
Senseonics, Incorporated May 04, 2022 postapproval study protocol  
eversense e3 continuous glucose monitoring system

supplement #: S019
Senseonics, Incorporated May 24, 2022 postapproval study protocol  
eversense® e3 continuous glucose monitoring (cgm) system

supplement #: S021
Senseonics, Incorporated Mar 29, 2023 change design/components/specifications/material Approval Order
Summary of Safety & Effectiveness
Labeling
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