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.
Modification of equipment and processes used to encase the eversense sensor. The eversense sensor is a component of the eversense continuous glucose monitoring system.
| Device | Eversense Continuous Glucose Monitoring System |
| Classification Name | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Generic Name | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Applicant | Senseonics, Incorporated |
| Date Received | 2019-06-24 |
| Decision Date | 2019-07-24 |
| PMA | P160048 |
| Supplement | S010 |
| Product Code | QCD |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |