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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 (CGMS-Entire System), Eversense Sensor, Eversense Insertion Tools, Everse
Generic NameContinuous glucose monitor, implanted, adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Pkwy.
Germantown, MD 20876
PMA NumberP160048
Supplement NumberS002
Date Received08/07/2018
Decision Date11/06/2018
Product Code QCD 
Advisory Committee Clinical Chemistry
Clinical TrialsNCT02154126
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
Approval for modifying the instructions for use of the Eversense Continuous Glucose Monitoring System to specify that, in addition to physicians, nurse practitioners and physicians assistants who have completed the required training may insert and remove the Eversense sensor.
Post-Approval StudyShow Report Schedule and Study Progress
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