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 Alterra Adaptive Prestent System |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Edwards Lifesciences, LLCone Edwards Wayirvine, CA 92614 PMA NumberP200015 Supplement NumberS022 Date Received06/06/2022 Decision Date07/06/2022 Product Code NPV Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-06-06 |
| Decision Date | 2022-07-06 |
| PMA | P200015 |
| Supplement | S022 |
| 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 NumberS022 Date Received06/06/2022 Decision Date07/06/2022 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 changes To The Alterra Prestent Visual Receiving Inspection Acceptance Criteria And The Austenite Start Temperature Specification Of The Nitinol Ingots Used To Manufacture The Frame |
| 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 |