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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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 System
Generic NameSensor, glucose, implanted, non-adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Parkway
Germantown, MD 20876-7005
PMA NumberP160048
Supplement NumberS016
Date Received09/30/2020
Decision Date02/10/2022
Product Code QHJ 
Docket Number 22M-0171
Notice Date 02/15/2022
Advisory Committee Clinical Chemistry
Clinical TrialsNCT03808376
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for the Eversense® E3 Continuous Glucose Monitoring System for expanding the indications for use and modifying the sensor design to allow use for up to 180 days.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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