Approval of the edwards pericardial aortic bioprosthesis and edwards inspiris resilia aortic valve. The edwards pericardial aortic bioprosthesis, model 11000a, is indicated for the replacement of native or prosthetic aortic heart valves. The edwards inspiris resilia aortic valve, model 11500a, is indicated for the replacement of native or prosthetic aortic heart valves.
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150048 | | Original Filing |
| S069 |
2022-10-12 |
30-day Notice |
| S068 |
2022-08-25 |
30-day Notice |
| S067 |
2022-08-15 |
30-day Notice |
| S066 |
2022-07-25 |
30-day Notice |
| S065 | | |
| S064 |
2022-04-06 |
30-day Notice |
| S063 |
2022-04-06 |
30-day Notice |
| S062 | | |
| S061 |
2022-03-08 |
30-day Notice |
| S060 | | |
| S059 |
2021-10-19 |
30-day Notice |
| S058 |
2021-09-27 |
30-day Notice |
| S057 |
2021-08-11 |
30-day Notice |
| S056 | | |
| S055 |
2021-06-24 |
30-day Notice |
| S054 |
2021-05-12 |
30-day Notice |
| S053 |
2021-03-16 |
30-day Notice |
| S052 |
2021-02-24 |
30-day Notice |
| S051 |
2020-11-16 |
30-day Notice |
| S050 |
2020-10-28 |
30-day Notice |
| S049 |
2020-10-06 |
30-day Notice |
| S048 |
2020-08-12 |
30-day Notice |
| S047 | | |
| S046 |
2020-06-26 |
30-day Notice |
| S045 | | |
| S044 |
2020-02-07 |
30-day Notice |
| S043 | | |
| S042 |
2019-11-18 |
30-day Notice |
| S041 |
2019-11-01 |
30-day Notice |
| S040 |
2019-10-28 |
30-day Notice |
| S039 |
2019-10-18 |
30-day Notice |
| S038 |
2019-09-17 |
30-day Notice |
| S037 |
2019-08-27 |
30-day Notice |
| S036 |
2019-05-31 |
30-day Notice |
| S035 |
2019-05-30 |
30-day Notice |
| S034 | | |
| S033 | | |
| S032 |
2019-03-25 |
30-day Notice |
| S031 |
2019-01-31 |
30-day Notice |
| S030 |
2018-11-14 |
30-day Notice |
| S029 | | |
| S028 |
2018-10-31 |
30-day Notice |
| S027 |
2018-10-24 |
30-day Notice |
| S026 |
2018-09-07 |
Normal 180 Day Track No User Fee |
| S025 |
2018-07-17 |
Special (immediate Track) |
| S024 |
2018-07-09 |
30-day Notice |
| S023 |
2018-06-26 |
135 Review Track For 30-day Notice |
| S022 |
2018-05-25 |
30-day Notice |
| S021 |
2018-05-24 |
30-day Notice |
| S020 |
2018-04-23 |
30-day Notice |
| S019 |
2018-03-13 |
30-day Notice |
| S018 |
2018-02-28 |
30-day Notice |
| S017 |
2018-02-15 |
30-day Notice |
| S016 |
2018-02-15 |
30-day Notice |
| S015 |
2018-02-06 |
30-day Notice |
| S014 |
2018-02-06 |
30-day Notice |
| S013 |
2018-01-09 |
30-day Notice |
| S012 |
2017-12-01 |
Panel Track |
| S011 |
2017-11-13 |
135 Review Track For 30-day Notice |
| S010 |
2017-11-09 |
30-day Notice |
| S009 |
2017-11-09 |
135 Review Track For 30-day Notice |
| S008 |
2017-11-01 |
30-day Notice |
| S007 |
2017-10-31 |
30-day Notice |
| S006 |
2017-09-27 |
135 Review Track For 30-day Notice |
| S005 |
2017-08-17 |
135 Review Track For 30-day Notice |
| S004 |
2017-08-09 |
30-day Notice |
| S003 |
2017-08-08 |
Normal 180 Day Track No User Fee |
| S002 |
2017-07-27 |
30-day Notice |
| S001 |
2017-07-25 |
Normal 180 Day Track No User Fee |
NIH GUDID Devices