Approval for the edwards sapien 3 transcatheter heart valve (thv) system with commander delivery system is indicated for use in the management of pediatric and adult patients who have a clinical indication for intervention on a dysfunctional right ventricular outflow tract (rvot) conduit or surgical bioprosthetic valve in the pulmonic position with greater than or equal to moderate regurgitation and/or a mean rvot gradient of greater than or equal to 35 mmhg.
| Device | Edwards SAPIEN 3 Transcatheter Heart Valve System with Edwards Commander Delivery System |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Edwards Lifesciences, LLC |
| Date Received | 2020-03-09 |
| Decision Date | 2020-08-31 |
| Notice Date | 2020-09-02 |
| PMA | P200015 |
| Supplement | S |
| Product Code | NPV |
| Docket Number | 20M-1835 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Edwards Lifesciences, LLC one Edwards Way irvine, CA 92614 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| 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 | | |
NIH GUDID Devices