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.
| Device | Edwards Pericardial Aortic Bioprosthesis, Edwards Pericardial Mitral Bioprosthesis, INSPIRIS™ RESILIA™ Aortic Valve, KON |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614-5688 PMA NumberP150048 Supplement NumberS067 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-15 |
| Decision Date | 2022-09-12 |
| PMA | P150048 |
| Supplement | S067 |
| 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 PMA NumberP150048 Supplement NumberS067 Date Received08/15/2022 Decision Date09/12/2022 Product Code LWR Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Outsource Polyester Band Manufacturing Steps Currently Performed In-house To An Existing Supplier |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00690103195019 | P150048 | 000 |
| 00690103195002 | P150048 | 000 |
| 00690103194999 | P150048 | 000 |
| 00690103194982 | P150048 | 000 |
| 00690103194975 | P150048 | 000 |
| 00690103194968 | P150048 | 000 |
| 00690103193855 | P150048 | 029 |
| 00690103201369 | P150048 | 029 |
| 00690103201376 | P150048 | 029 |
| 00690103201383 | P150048 | 029 |
| 00690103201390 | P150048 | 029 |
| 00690103201406 | P150048 | 029 |
| 00690103205572 | P150048 | 047 |
| 00690103205565 | P150048 | 047 |
| 00690103205558 | P150048 | 047 |
| 00690103205541 | P150048 | 047 |
| 00690103205534 | P150048 | 047 |