This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the mitroflow aortic pericardial heart valve, sizes 19, 21, 23, 25, and 27 mm. The device is intended for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
| Device | MITROFLOW AORTIC PERICARDIAL HEART VALVE |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | LivaNova Canada Corp. |
| Date Received | 2006-12-18 |
| Decision Date | 2007-10-23 |
| Notice Date | 2007-11-09 |
| PMA | P060038 |
| Supplement | S |
| Product Code | LWR |
| Docket Number | 07M-0410 |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 00896208000559 | P060038 | 002 |
| 00896208000139 | P060038 | 002 |
| 00896208000122 | P060038 | 002 |
| 00896208000115 | P060038 | 002 |
| 00896208000108 | P060038 | 002 |
| 00896208000092 | P060038 | 002 |
| 08022057014955 | P060038 | 012 |
| 08022057014948 | P060038 | 012 |
| 08022057014931 | P060038 | 012 |
| 08022057014924 | P060038 | 012 |
| 00896208000160 | P060038 | 017 |
| 00896208000153 | P060038 | 017 |
| 00896208000191 | P060038 | 017 |
| 00896208000184 | P060038 | 017 |
| 00896208000177 | P060038 | 017 |
| 00896208000504 | P060038 | 026 |
| 00896208000528 | P060038 | 026 |
| 00896208000535 | P060038 | 026 |
| 00896208000542 | P060038 | 026 |
| 00896208000511 | P060038 | 026 |