Approval for a change to the sterility testing of the final storage solution.
| Device | SOLO SMART STENTLESS HEART VALVE (SOLO SMART) |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | LivaNova Canada Corp. |
| Date Received | 2015-12-07 |
| Decision Date | 2016-02-09 |
| PMA | P130011 |
| Supplement | S002 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | LivaNova Canada Corp. 5005 North Fraser Way burnaby V5J 5 |
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