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 Pulmonary Valve System with Alterra Adaptive Prestent |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS021 Date Received05/25/2022 Decision Date06/23/2022 Product Code NPV Advisory Committee Cardiovascular Clinical TrialsNCT05378386 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No |
| Date Received | 2022-05-25 |
| Decision Date | 2022-06-23 |
| PMA | P200015 |
| Supplement | S021 |
| Product Code | NPV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Edwards Lifesciences, LLC one Edwards Way irvine, CA 92614 PMA NumberP200015 Supplement NumberS021 Date Received05/25/2022 Decision Date06/23/2022 Product Code NPV Advisory Committee Cardiovascular Clinical TrialsNCT05378386 Supplement Typenormal 180 Day Track No User Fee Supplement Reason Postapproval Study Protocol Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval Of The Revised Protocol For The Post-approval Study 2: Alterra New Enrollment Study. |
| 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 |