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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 NumberS012
Date Received07/03/2019
Decision Date11/25/2019
Product Code QHJ 
Advisory Committee Clinical Chemistry
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
Approval of the protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P160048/S006
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