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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceEversense E3 Continuous Glucose Monitoring System, Eversense E3 Sensor, Eversense Insertion Tools, Eversense Smart Trans
Generic NameContinuous glucose monitor, implanted, adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown, MD 20876
PMA NumberP160048
Supplement NumberS028
Date Received09/27/2024
Decision Date10/23/2024
Product Code QCD 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02154126
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
to move finished Eversense Insertion Tool device manufacturing activities from one building to the neighboring building within the same establishment that has the same FEI. The Eversense Insertion Tool is a component of the Eversense E3 Continuous Glucose Monitoring System
Post-Approval StudyShow Report Schedule and Study Progress
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