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. |
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Device | Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers |
Generic Name | Continuous glucose monitor, implanted, adjunctive use |
Applicant | Senseonics, Incorporated 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 |
PMA Number | P160048 |
Supplement Number | S003 |
Date Received | 08/27/2018 |
Decision Date | 02/01/2019 |
Product Code |
QCD |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
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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