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.
Implementation of an autoclave for laboratory supplies and equipment sterilization
| Device | Edwards Pericardial Aortic Bioprosthesis, Edwards INSPIRIS RESILIA Aortic Valve |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | EDWARDS LIFESCIENCES, LLC. |
| Date Received | 2020-11-16 |
| Decision Date | 2020-12-13 |
| PMA | P150048 |
| Supplement | S051 |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P150048 | Original Filing | |
| 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 |