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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 (CGM) System
Generic NameSensor, glucose, implanted, non-adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown, MD 20876
PMA NumberP160048
Supplement NumberS022
Date Received01/31/2023
Decision Date03/30/2023
Product Code QHJ 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02154126
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for modifying the Eversense E3 Transmitter, supporting mobile medical application, and the Instructions for Use for consistent use with the modified transmitter.
Post-Approval StudyShow Report Schedule and Study Progress
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