Approval for manufacturing process changes to the mitroflow aortic pericardial heart valve, model lx, consisting of implementation of the phospholipid reduction treatment manufacturing process (an anticalcification treatment process). The device, as modified, will be marketed under the trade name mitroflow aortic pericardial heart valve with phospholipid reduction treatment, model dl and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
| Device | MITROFLOW AORTIC PERICARDIAL HEART VALVE WITH PHOSPHOLIPID REDUCTION TREATMENT, MODEL DL |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | LivaNova Canada Corp. |
| Date Received | 2013-07-01 |
| Decision Date | 2014-04-18 |
| PMA | P060038 |
| Supplement | S017 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
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