Approval for minor design modifications to the mitroflow aortic pericardial heart valve model dl, namely the addition of radiographic markers on the sewing ring and addition of visible markers on the sewing cuff. The device, as modified, will be marketed under the trade name crown prt aortic pericardial heart valve with pr treatment and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
| Device | Crown PRT Aortic Pericardial Heart Valve with PR Treatment |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | LivaNova Canada Corp. |
| Date Received | 2015-11-04 |
| Decision Date | 2016-01-13 |
| PMA | P060038 |
| Supplement | S026 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |
|---|
| P060038 | | Original Filing |
| S033 |
2019-04-08 |
Normal 180 Day Track No User Fee |
| S032 |
2018-06-15 |
30-day Notice |
| S031 |
2017-12-26 |
135 Review Track For 30-day Notice |
| S030 |
2016-08-16 |
30-day Notice |
| S029 |
2016-08-11 |
135 Review Track For 30-day Notice |
| S028 |
2016-06-17 |
30-day Notice |
| S027 |
2016-03-31 |
30-day Notice |
| S026 |
2015-11-04 |
Real-time Process |
| S025 |
2015-09-28 |
Real-time Process |
| S024 |
2015-09-22 |
Real-time Process |
| S023 |
2015-03-27 |
30-day Notice |
| S022 |
2014-12-22 |
30-day Notice |
| S021 |
2014-09-22 |
Normal 180 Day Track No User Fee |
| S020 |
2014-05-16 |
Normal 180 Day Track No User Fee |
| S019 |
2014-02-24 |
30-day Notice |
| S018 |
2013-10-28 |
30-day Notice |
| S017 |
2013-07-01 |
Normal 180 Day Track |
| S016 | | |
| S015 |
2012-10-04 |
30-day Notice |
| S014 |
2012-07-10 |
30-day Notice |
| S013 | | |
| S012 |
2012-04-12 |
Normal 180 Day Track No User Fee |
| S011 |
2012-02-21 |
30-day Notice |
| S010 |
2011-07-22 |
135 Review Track For 30-day Notice |
| S009 |
2011-01-05 |
30-day Notice |
| S008 |
2010-12-23 |
30-day Notice |
| S007 |
2010-06-11 |
30-day Notice |
| S006 |
2009-07-22 |
30-day Notice |
| S005 |
2009-07-08 |
30-day Notice |
| S004 |
2009-05-27 |
135 Review Track For 30-day Notice |
| S003 |
2009-03-19 |
30-day Notice |
| S002 |
2008-12-29 |
Real-time Process |
| S001 |
2008-04-02 |
135 Review Track For 30-day Notice |
NIH GUDID Devices