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.
Approval for a design change to the sensor component of the eversense continuous glucose monitoring system
| Device | Eversense Continuous Glucose Monitoring System |
| Classification Name | Sensor, Glucose, Implanted, Non-adjunctive Use |
| Generic Name | Sensor, Glucose, Implanted, Non-adjunctive Use |
| Applicant | Senseonics, Incorporated |
| Date Received | 2019-06-27 |
| Decision Date | 2019-08-29 |
| PMA | P160048 |
| Supplement | S011 |
| Product Code | QHJ |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Senseonics, Incorporated 20451 Seneca Meadows Parkway germantown, MD 20876-7005 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P160048 | Original Filing | |
| S017 | 2020-11-12 | 30-day Notice |
| S016 | ||
| S015 | ||
| S014 | 2019-08-27 | Normal 180 Day Track No User Fee |
| S013 | 2019-07-31 | 30-day Notice |
| S012 | ||
| S011 | 2019-06-27 | Normal 180 Day Track |
| S010 | 2019-06-24 | 30-day Notice |
| S009 | 2019-05-28 | 30-day Notice |
| S008 | 2018-12-11 | Real-time Process |
| S007 | 2018-11-28 | Normal 180 Day Track No User Fee |
| S006 | ||
| S005 | 2018-09-11 | Real-time Process |
| S004 | 2018-09-07 | Real-time Process |
| S003 | 2018-08-27 | Normal 180 Day Track No User Fee |
| S002 | 2018-08-07 | Normal 180 Day Track |
| S001 | 2018-07-20 | Normal 180 Day Track No User Fee |