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 SAPIEN 3™ Transcatheter Heart Valve |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS027 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-08-25 |
| Decision Date | 2022-09-23 |
| PMA | P200015 |
| Supplement | S027 |
| Product Code | NPV |
| 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 NumberP200015 Supplement NumberS027 Date Received08/25/2022 Decision Date09/23/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement implementation Of An Enhanced Temperature Indicator Packaging Component To Monitor Surgical And Transcatheter Heart Valves During Transit And Storage |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200015 | Original Filing | |
| S032 | 2022-11-14 | 30-day Notice |
| S031 | 2022-10-25 | 30-day Notice |
| S030 | 2022-10-04 | 30-day Notice |
| S029 | ||
| S028 | ||
| S027 | 2022-08-25 | 30-day Notice |
| S026 | ||
| S025 | ||
| S024 | ||
| S023 | 2022-06-30 | 30-day Notice |
| S022 | 2022-06-06 | 30-day Notice |
| S021 | 2022-05-25 | Normal 180 Day Track No User Fee |
| S020 | ||
| S019 | 2022-04-04 | 30-day Notice |
| S018 | ||
| S017 | 2022-01-14 | 30-day Notice |
| S016 | 2021-11-03 | Normal 180 Day Track No User Fee |
| S015 | 2021-10-19 | 30-day Notice |
| S014 | 2021-09-30 | 30-day Notice |
| S013 | 2021-08-30 | 30-day Notice |
| S012 | 2021-08-25 | 30-day Notice |
| S011 | ||
| S010 | 2021-06-07 | Normal 180 Day Track No User Fee |
| S009 | 2021-03-19 | Normal 180 Day Track No User Fee |
| S008 | 2021-02-22 | 30-day Notice |
| S007 | 2020-12-17 | 30-day Notice |
| S006 | 2020-12-03 | 30-day Notice |
| S005 | ||
| S004 | 2020-09-08 | 30-day Notice |
| S003 | 2020-11-17 | 30-day Notice |
| S002 | 2020-11-02 | 30-day Notice |
| S001 |
| Device ID | PMA | Supp |
|---|---|---|
| 00690103210866 | P200015 | 011 |
| 00690103210873 | P200015 | 011 |