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 (CGM) 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 | S022 |
Date Received | 01/31/2023 |
Decision Date | 03/30/2023 |
Product Code |
QHJ |
Advisory Committee |
Clinical Chemistry |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Approval for modifying the Eversense E3 Transmitter, supporting mobile medical application, and the Instructions for Use for consistent use with the modified transmitter. |
|
|