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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 CGM System
Generic NameSensor, glucose, implanted, non-adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown, MD 20876
PMA NumberP160048
Supplement NumberS024
Date Received04/14/2023
Decision Date05/10/2023
Product Code QHJ 
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  
Addition of a new supplier for a critical component of the Eversense E3 Transmitter. The transmitter is a component of the Eversense Continuous Glucose Monitoring System.
Post-Approval StudyShow Report Schedule and Study Progress
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