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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 NameContinuous glucose monitor, implanted, adjunctive use
ApplicantSenseonics, Incorporated
20451 Seneca Meadows Parkway
Germantown, MD 20876-7005
PMA NumberP160048
Supplement NumberS008
Date Received12/11/2018
Decision Date01/28/2019
Product Code QCD 
Advisory Committee Clinical Chemistry
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval to label the Eversense Sensor as Magnetic Resonance (MR) Conditional.
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