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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 Continuous Glucose Monitoring System
Generic NameSensor, glucose, implanted, non-adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Parkway
Germantown, MD 20876-7005
PMA NumberP160048
Supplement NumberS011
Date Received06/27/2019
Decision Date08/29/2019
Product Code QHJ 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval for a design change to the sensor component of the Eversense Continuous Glucose Monitoring System.
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