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.
The addition of a sterilization chamber (chamber 5) at the steris sterilization facility in costa rica
| Device | Amplatzer Amulet Left Atrial Appendage Occluder |
| Generic Name | System, Appendage Closure, Left Atrial |
| Applicant | Abbott Medical |
| Date Received | 2021-08-24 |
| Decision Date | 2021-09-22 |
| PMA | P200049 |
| Supplement | S001 |
| 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 |