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. |
|
Device | Eversense E3 Continuous Glucose Monitoring System (CGM System) - Entire System, Eversense E3 Sensor, Eversense E3 Insert |
Generic Name | Continuous glucose monitor, implanted, adjunctive use |
Applicant | Senseonics, Incorporated 20451 Seneca Meadows Parkway Germantown, MD 20876-7005 |
PMA Number | P160048 |
Supplement Number | S026 |
Date Received | 08/11/2023 |
Decision Date | 12/05/2023 |
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 for a manufacturing site located at RR Donnelley - Supply Chain Solutions, 1600 Disk Dr., Plover, WI 54467-3131, to perform kitting of the final components, labeling, storage, and distribution of the Eversense E3 CGM System. |
|
|