Approval for the freedom solo stentless heart valve and solo smart stentless heart valve. These devices are indicated for the replacement of diseased, damaged, or malfunctioning native or prostheticaortic valves.
| Device | FREEDOM SOLO STENTLESS HEART VALVE |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | LivaNova Canada Corp. |
| Date Received | 2013-05-13 |
| Decision Date | 2014-06-24 |
| Notice Date | 2014-07-23 |
| PMA | P130011 |
| Supplement | S |
| Product Code | LWR |
| Docket Number | 14M-1064 |
| 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 |
| Approval Order: | Approval Order |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P130011 | | Original Filing |
| S011 |
2022-06-29 |
30-day Notice |
| S010 |
2022-03-03 |
30-day Notice |
| S009 |
2020-03-02 |
30-day Notice |
| S008 |
2020-01-13 |
30-day Notice |
| S007 |
2019-03-01 |
30-day Notice |
| S006 |
2018-02-07 |
30-day Notice |
| S005 |
2016-08-11 |
135 Review Track For 30-day Notice |
| S004 |
2016-03-31 |
30-day Notice |
| S003 |
2016-01-27 |
135 Review Track For 30-day Notice |
| S002 |
2015-12-07 |
135 Review Track For 30-day Notice |
| S001 |
2015-06-22 |
30-day Notice |
NIH GUDID Devices