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 to add final packaging, storage, and distribution activities for the eversense continuous glucose monitoring system at woodfield distribution, llc, boca raton, fl.
| Device | Eversense Continuous Glucose Monitoring System (CGMS-Entire System), Eversense Sensor , Eversense Insertion Tools, Evers |
| Classification Name | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Generic Name | Continuous Glucose Monitor, Implanted, Adjunctive Use |
| Applicant | SENSEONICS, INCORPORATED |
| Date Received | 2018-08-27 |
| Decision Date | 2019-02-01 |
| PMA | P160048 |
| Supplement | S003 |
| Product Code | QCD |
| Advisory Committee | Clinical Chemistry |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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 |