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.
Addition of an alternative crimping accessory packaged with the edwards delivery systems
| Device | Edwards SAPIEN 3 Transcatheter Heart Valve and Accessories, Pulmonic Indication |
| Generic Name | Pulmonary Valve Prosthesis Percutaneously Delivered |
| Applicant | Edwards Lifesciences, LLC |
| Date Received | 2020-11-17 |
| Decision Date | 2020-12-16 |
| PMA | P200015 |
| Supplement | S003 |
| 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 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200015 | Original Filing | |
| 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 |