Approval for the perceval sutureless heart valve. This device is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
| Device | PERCEVAL SUTURELESS HEART VALVE |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | LivaNova Canada Corp. |
| Date Received | 2015-03-02 |
| Decision Date | 2016-01-08 |
| Notice Date | 2016-01-11 |
| PMA | P150011 |
| Supplement | S |
| Product Code | LWR |
| Docket Number | 16M-0123 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LivaNova Canada Corp. 5005 North Fraser Way burnaby V5J 5 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P150011 | | Original Filing |
| S026 |
2022-10-24 |
30-day Notice |
| S025 |
2022-06-29 |
30-day Notice |
| S024 | | |
| S023 |
2022-03-03 |
30-day Notice |
| S022 |
2021-02-16 |
30-day Notice |
| S021 | | |
| S020 |
2020-03-16 |
Real-time Process |
| S019 |
2020-03-02 |
30-day Notice |
| S018 |
2020-01-13 |
30-day Notice |
| S017 |
2019-10-17 |
30-day Notice |
| S016 |
2019-03-01 |
30-day Notice |
| S015 |
2019-01-22 |
Special (immediate Track) |
| S014 |
2018-12-10 |
Special (immediate Track) |
| S013 | | |
| S012 |
2018-02-07 |
30-day Notice |
| S011 |
2017-07-24 |
135 Review Track For 30-day Notice |
| S010 |
2017-06-26 |
30-day Notice |
| S009 |
2017-02-16 |
30-day Notice |
| S008 |
2017-01-27 |
30-day Notice |
| S007 |
2017-01-19 |
30-day Notice |
| S006 |
2016-12-15 |
Special (immediate Track) |
| S005 |
2016-08-11 |
135 Review Track For 30-day Notice |
| S004 |
2016-04-06 |
30-day Notice |
| S003 |
2016-03-31 |
30-day Notice |
| S002 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S001 |
2016-01-27 |
30-day Notice |
NIH GUDID Devices