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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

Senseonics, Incorporated Jun 21, 2018   Approval Order
Summary of Safety & Effectiveness
Labeling
eversense continuous glucose monitoring system

supplement #: S001
Senseonics, Incorporated Sep 18, 2018 postapproval study protocol  
eversense continuous glucose monitoring system (cgms-entire system), eversense sensor, eversense insertion tools, everse

supplement #: S002
Senseonics, Incorporated Nov 06, 2018 labeling change - indications/instructions/shelf life/tradename  
eversense continuous glucose monitoring system (cgms-entire system), eversense sensor , eversense insertion tools, evers

supplement #: S003
Senseonics, Incorporated Feb 01, 2019 location change - manufacturer/sterilizer/packager/supplier  
eversense continuous glucose monitoring system

supplement #: S004
Senseonics, Incorporated Dec 06, 2018 change design/components/specifications/material  
eversense continuous glucose monitoring system

supplement #: S005
Senseonics, Incorporated Dec 07, 2018 change design/components/specifications/material  
eversense continuous glucose monitoring system

supplement #: S006
Senseonics, Incorporated Jun 06, 2019 labeling change - indications/instructions/shelf life/tradename Approval Order
Summary of Safety & Effectiveness
Labeling
eversense continuous glucose monitoring system

supplement #: S007
Senseonics, Incorporated Jan 15, 2019 labeling change - indications/instructions/shelf life/tradename  
eversense continuous glucose monitoring system

supplement #: S008
Senseonics, Incorporated Jan 28, 2019 labeling change - indications/instructions/shelf life/tradename  
eversense continuous glucose monitoring system

supplement #: S009
Senseonics, Incorporated Jun 26, 2019 process change - manufacturer/sterilizer/packager/supplier  
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