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.
| Device | PorticoTM Transcatheter Aortic Valve Implantation System |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS010 Date Received08/12/2022 Decision Date11/09/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-08-12 |
| Decision Date | 2022-11-09 |
| PMA | P190023 |
| Supplement | S010 |
| Product Code | NPT |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 177 County Road B. East st. Paul, MN 55117 PMA NumberP190023 Supplement NumberS010 Date Received08/12/2022 Decision Date11/09/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement approval For Modifications To The Packaging Design For The FlexNav Delivery System |
| 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 |