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.
Approval of the protocol for the post approval study "registry-based real world use surveillance of the portico tavi system. "
| Device | Portico Heart Valve, FlexNav Delivery System, FlexNav Loading System |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | Abbott Medical |
| Date Received | 2021-10-15 |
| Decision Date | 2021-11-12 |
| PMA | P190023 |
| Supplement | S001 |
| Product Code | NPT |
| 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 | Abbott Medical 177 County Road B. East st. Paul, MN 55117 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190023 | Original Filing | |
| S011 | 2022-11-18 | 30-day Notice |
| S010 | 2022-08-12 | Real-time Process |
| S009 | 2022-07-01 | 30-day Notice |
| S008 | 2022-06-08 | 30-day Notice |
| S007 | 2022-04-18 | 30-day Notice |
| S006 | 2022-02-18 | 30-day Notice |
| S005 | ||
| S004 | 2021-11-08 | 30-day Notice |
| S003 | 2021-10-25 | 135 Review Track For 30-day Notice |
| S002 | ||
| S001 | 2021-10-15 | Normal 180 Day Track No User Fee |