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 | Portico™ Transcatheter Aortic Heart Valve |
| Generic Name | Aortic Valve, Prosthesis, Percutaneously Delivered |
| Applicant | Abbott Medical177 County Road B. Eastst. Paul, MN 55117 PMA NumberP190023 Supplement NumberS007 Date Received04/18/2022 Decision Date04/20/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-04-18 |
| Decision Date | 2022-04-20 |
| PMA | P190023 |
| Supplement | S007 |
| Product Code | NPT |
| 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 177 County Road B. East st. Paul, MN 55117 PMA NumberP190023 Supplement NumberS007 Date Received04/18/2022 Decision Date04/20/2022 Product Code NPT Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of One New Abattoir |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05415067010728 | P190023 | 000 |
| 05415067031440 | P190023 | 000 |
| 05415067031433 | P190023 | 000 |
| 05415067031389 | P190023 | 000 |
| 05415067031372 | P190023 | 000 |
| 05415067012500 | P190023 | 000 |
| 05415067012494 | P190023 | 000 |
| 05415067012487 | P190023 | 000 |
| 05415067031570 | P190023 | 002 |
| 05415067031587 | P190023 | 002 |
| 05415067031594 | P190023 | 002 |
| 05415067031600 | P190023 | 002 |
| 05415067036650 | P190023 | 002 |
| 05415067036667 | P190023 | 002 |
| 05415067045805 | P190023 | 013 |
| 05415067045799 | P190023 | 013 |
| 05415067045782 | P190023 | 013 |
| 05415067045775 | P190023 | 013 |
| 05415067045768 | P190023 | 013 |
| 05415067048417 | P190023 | 013 |