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 |
Generic Name | Sensor, glucose, implanted, non-adjunctive use |
Applicant | Senseonics, Incorporated 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 |
PMA Number | P160048 |
Supplement Number | S014 |
Date Received | 08/27/2019 |
Decision Date | 10/29/2019 |
Product Code |
QHJ |
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 for a manufacturing site located at Steris Isomedix Services, 3459 South Clinton Ave., South Plainfield, NJ 07080 for use as a sterilization site for the sensor insertion tools of the Eversense Continuous Glucose Monitoring System. |
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