Approval for the lotus edge valve system. The device is indicated for relief of aortic stenosis in patients with symptomatic heart disease due to severe native calcific aortic stenosis (aortic valve area [ava] of
| Device | LOTUS Edge Valve System |
| Classification Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | Boston Scientific Corporation |
| Date Received | 2018-08-14 |
| Decision Date | 2019-04-23 |
| PMA | P180029 |
| Supplement | S |
| Product Code | NPT |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752-1234 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P180029 | Original Filing | |
| S030 | 2021-03-01 | Normal 180 Day Track No User Fee |
| S029 | ||
| S028 | 2020-11-02 | 30-day Notice |
| S027 | 2020-09-21 | 30-day Notice |
| S026 | 2020-09-14 | 30-day Notice |
| S025 | 2020-08-10 | 30-day Notice |
| S024 | 2020-06-08 | 30-day Notice |
| S023 | 2020-04-13 | 30-day Notice |
| S022 | ||
| S021 | 2020-03-06 | 30-day Notice |
| S020 | ||
| S019 | 2019-12-09 | 30-day Notice |
| S018 | ||
| S017 | 2019-11-12 | 30-day Notice |
| S016 | 2019-10-15 | 30-day Notice |
| S015 | 2019-10-07 | 30-day Notice |
| S014 | 2019-09-30 | 30-day Notice |
| S013 | ||
| S012 | 2019-09-23 | 30-day Notice |
| S011 | ||
| S010 | 2019-08-19 | 30-day Notice |
| S009 | 2019-08-12 | 30-day Notice |
| S008 | ||
| S007 | 2019-06-27 | 30-day Notice |
| S006 | 2019-06-17 | 30-day Notice |
| S005 | ||
| S004 | 2019-06-03 | 30-day Notice |
| S003 | ||
| S002 | ||
| S001 | 2019-05-06 | 30-day Notice |