This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the device.
| Device | MITROFLOW AORTIC PERICARDIAL HEART VALVE (MAPHV) |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | LivaNova Canada Corp. |
| Date Received | 2012-04-12 |
| Decision Date | 2012-10-09 |
| PMA | P060038 |
| Supplement | S012 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| 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 |
| 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 |