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 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 | S010 |
Date Received | 06/24/2019 |
Decision Date | 07/24/2019 |
Product Code |
QHJ |
Advisory Committee |
Clinical Chemistry |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | Yes |
Approval Order Statement Modification of equipment and processes used to encase the Eversense sensor. The Eversense sensor is a component of the Eversense Continuous Glucose Monitoring system. |
|
|