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.
Manufacturing and specification changes to the adaptive seal component of the 27-mm lotus edge valve
| 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 | 2019-06-03 |
| Decision Date | 2019-06-22 |
| PMA | P180029 |
| Supplement | S004 |
| Product Code | NPT |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Boston Scientific Corporation 300 Boston Scientific Way marlborough, MA 01752-1234 |
| 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 |