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 INTUITY Elite Valve System |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | EDWARDS LIFESCIENCES, LLC.one Edwards Wayirvine, CA 92614 PMA NumberP150036 Supplement NumberS063 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 | P150036 |
| Supplement | S063 |
| 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 PMA NumberP150036 Supplement NumberS063 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 |
|---|---|---|
| P150036 | Original Filing | |
| S065 | 2022-10-12 | 30-day Notice |
| S064 | 2022-08-25 | 30-day Notice |
| S063 | 2022-08-15 | 30-day Notice |
| S062 | 2022-03-22 | 30-day Notice |
| S061 | ||
| S060 | 2022-03-08 | 30-day Notice |
| S059 | 2021-10-19 | 30-day Notice |
| S058 | 2021-09-27 | 30-day Notice |
| S057 | ||
| S056 | 2021-08-11 | 30-day Notice |
| S055 | 2021-08-02 | 30-day Notice |
| S054 | 2020-11-16 | 30-day Notice |
| S053 | 2020-10-28 | 30-day Notice |
| S052 | 2020-08-10 | 30-day Notice |
| S051 | 2020-03-19 | 30-day Notice |
| S050 | 2020-02-10 | 30-day Notice |
| S049 | 2020-02-07 | 30-day Notice |
| S048 | ||
| S047 | 2019-11-18 | 30-day Notice |
| S046 | 2019-11-13 | 30-day Notice |
| S045 | 2019-11-01 | 30-day Notice |
| S044 | 2019-10-28 | 30-day Notice |
| S043 | 2019-10-18 | 30-day Notice |
| S042 | ||
| S041 | 2019-08-27 | 30-day Notice |
| S040 | 2019-05-31 | 30-day Notice |
| S039 | ||
| S038 | ||
| S037 | 2019-01-31 | 30-day Notice |
| S036 | 2018-11-16 | 30-day Notice |
| S035 | 2018-11-14 | 30-day Notice |
| S034 | 2018-10-31 | 30-day Notice |
| S033 | 2018-10-24 | 30-day Notice |
| S032 | 2018-07-16 | 30-day Notice |
| S031 | 2018-07-09 | 30-day Notice |
| S030 | 2018-05-25 | 30-day Notice |
| S029 | 2018-04-23 | 30-day Notice |
| S028 | 2018-03-13 | 30-day Notice |
| S027 | 2018-02-28 | 30-day Notice |
| S026 | 2018-02-28 | 30-day Notice |
| S025 | 2018-02-15 | 30-day Notice |
| S024 | 2018-01-09 | 30-day Notice |
| S023 | 2017-12-22 | 30-day Notice |
| S022 | 2017-11-13 | 135 Review Track For 30-day Notice |
| S021 | 2017-11-09 | 30-day Notice |
| S020 | 2017-10-31 | 30-day Notice |
| S019 | 2017-09-27 | 135 Review Track For 30-day Notice |
| S018 | 2017-08-09 | 30-day Notice |
| S017 | 2017-08-03 | 30-day Notice |
| S016 | 2017-07-25 | 30-day Notice |
| S015 | 2017-06-30 | 30-day Notice |
| S014 | 2017-06-22 | 30-day Notice |
| S013 | 2017-06-19 | 30-day Notice |
| S012 | 2017-05-24 | 30-day Notice |
| S011 | 2017-05-12 | 30-day Notice |
| S010 | 2017-05-04 | 30-day Notice |
| S009 | ||
| S008 | 2017-04-25 | 30-day Notice |
| S007 | 2017-04-10 | 30-day Notice |
| S006 | 2017-03-23 | 30-day Notice |
| S005 | 2017-01-30 | 30-day Notice |
| S004 | 2017-01-18 | 30-day Notice |
| S003 | 2017-01-11 | 30-day Notice |
| S002 | 2016-12-12 | 135 Review Track For 30-day Notice |
| S001 | 2016-11-15 | 135 Review Track For 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00690103194562 | P150036 | 000 |
| 00690103192551 | P150036 | 000 |
| 00690103192568 | P150036 | 000 |
| 00690103192575 | P150036 | 000 |
| 00690103192582 | P150036 | 000 |
| 00690103194470 | P150036 | 000 |
| 00690103194487 | P150036 | 000 |
| 00690103194494 | P150036 | 000 |
| 00690103194500 | P150036 | 000 |
| 00690103194517 | P150036 | 000 |
| 00690103194524 | P150036 | 000 |
| 00690103194531 | P150036 | 000 |
| 00690103194548 | P150036 | 000 |
| 00690103194555 | P150036 | 000 |
| 00690103192544 | P150036 | 000 |