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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 (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers
Classification Namecontinuous glucose monitor, implanted, adjunctive use
Generic Namecontinuous glucose monitor, implanted, adjunctive use
Applicant
Senseonics, Incorporated
20451 seneca meadows parkway
germantown, MD 20876-7005
PMA NumberP160048
Supplement NumberS003
Date Received08/27/2018
Decision Date02/01/2019
Product Code
QCD[ Registered Establishments with QCD ]
Advisory Committee Clinical Chemistry
Supplement Typenormal 180 day track no user fee
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to add final packaging, storage, and distribution activities for the Eversense Continuous Glucose Monitoring System at Woodfield Distribution, LLC, Boca Raton, FL.
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