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.
An update to the dome weld and end screw weld visual acceptance criteria
| Device | Amplatzer Amulet Left Atrial Appendage Occluder |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Abbott Medical |
| Date Received | 2021-11-05 |
| Decision Date | 2021-11-16 |
| PMA | P200049 |
| Supplement | S003 |
| Product Code | NGV |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200049 | Original Filing | |
| S004 | 2022-06-16 | 30-day Notice |
| S003 | 2021-11-05 | 30-day Notice |
| S002 | ||
| S001 | 2021-08-24 | 30-day Notice |