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