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 |
Supplemental Filings
| 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 |
NIH GUDID Devices