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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 NumberS005
Date Received09/11/2018
Decision Date12/07/2018
Product Code QCD 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02154126
Supplement TypeReal-Time Process
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 a new LED for the Eversense sensor’s optical system.
Post-Approval StudyShow Report Schedule and Study Progress
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