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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® Continuous Glucose Monitoring System
Generic NameContinuous glucose monitor, implanted, adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown, MD 20876
PMA NumberP160048
Supplement NumberS031
Date Received02/23/2026
Decision Date03/19/2026
Product Code QCD 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02154126
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval of the revised protocol for the post-approval study (PAS) protocol.
Post-Approval StudyShow Report Schedule and Study Progress
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