Removal of the visual inspection for “open leaflet” in air for surgical pericardial heart valves.
| Device | Edwards Pericardial Aortic Bioprosthesis and Edwards INSPIRIS RESILIA Aortic Valve |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2018-10-24 |
| Decision Date | 2018-11-20 |
| PMA | P150048 |
| Supplement | S027 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | EDWARDS LIFESCIENCES, LLC. one Edwards Way irvine, CA 92614-5688 |
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