This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the eversense cgm system. The device is indicated for continually measuring glucose levels in adults (18 years and older) with diabetes for up to 90 days. The system is intended to:1) provide real-time glucose readings;2) provide glucose trend information; and3) provide alerts for the detection and prediction of episodes of low blood glucose (hypoglycemia) and high blood glucose (hyperglycemia). The system is a prescription device. Historical data from the system can be interpreted to aid in providing therapy adjustments. These adjustments should be based on patterns seen over time. The system is indicated for use as an adjunctive device to complement, not replace, information obtained from standard home blood glucose monitoring devices.
| 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 | 2016-10-26 |
| Decision Date | 2018-06-21 |
| Notice Date | 2018-07-24 |
| PMA | P160048 |
| Supplement | S |
| Product Code | QCD |
| Docket Number | 18M-2463 |
| Advisory Committee | Clinical Chemistry |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SENSEONICS, INCORPORATED 20451 Seneca Meadows Parkway germantown, MD 20876-7005 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |