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 multiple changes, including clinical changes to the current protocol for the post-approval study (pas) protocol.
| Device | ON-X (R) PROSTHETIC HEART VALVE, ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, ON-X AORTIC PROSTHETIC HEART VALVE WITH A |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | On-X Life Technologies, Inc. |
| Date Received | 2016-12-09 |
| Decision Date | 2017-02-07 |
| PMA | P000037 |
| Supplement | S048 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | On-X Life Technologies, Inc. 1655 Roberts Blvd Nw kennesaw, GA 30144 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000037 | Original Filing | |
| S060 | 2022-07-15 | 30-day Notice |
| S059 | 2022-03-01 | 30-day Notice |
| S058 | ||
| S057 | 2020-12-07 | Real-time Process |
| S056 | ||
| S055 | ||
| S054 | 2019-06-19 | Normal 180 Day Track No User Fee |
| S053 | 2018-12-31 | 30-day Notice |
| S052 | 2018-09-20 | Special (immediate Track) |
| S051 | 2017-07-05 | Normal 180 Day Track No User Fee |
| S050 | 2017-01-25 | 135 Review Track For 30-day Notice |
| S049 | ||
| S048 | 2016-12-09 | Normal 180 Day Track No User Fee |
| S047 | 2016-08-31 | 30-day Notice |
| S046 | 2016-07-11 | 30-day Notice |
| S045 | 2016-04-25 | 30-day Notice |
| S044 | 2015-11-13 | Normal 180 Day Track No User Fee |
| S043 | 2015-09-08 | 30-day Notice |
| S042 | ||
| S041 | 2015-04-20 | Normal 180 Day Track No User Fee |
| S040 | 2015-03-30 | 135 Review Track For 30-day Notice |
| S039 | 2015-02-27 | 30-day Notice |
| S038 | 2014-09-15 | 30-day Notice |
| S037 | 2014-08-27 | Normal 180 Day Track |
| S036 | 2014-06-03 | 135 Review Track For 30-day Notice |
| S035 | 2014-02-18 | 30-day Notice |
| S034 | ||
| S033 | 2013-06-07 | 135 Review Track For 30-day Notice |
| S032 | 2012-12-13 | 30-day Notice |
| S031 | 2012-11-14 | 30-day Notice |
| S030 | 2012-10-23 | Normal 180 Day Track |
| S029 | 2012-08-23 | 30-day Notice |
| S028 | 2012-06-28 | Normal 180 Day Track |
| S027 | 2012-06-14 | 30-day Notice |
| S026 | 2012-04-05 | 30-day Notice |
| S025 | 2012-03-20 | 135 Review Track For 30-day Notice |
| S024 | 2011-09-15 | 135 Review Track For 30-day Notice |
| S023 | 2011-06-24 | 30-day Notice |
| S022 | 2011-01-20 | 30-day Notice |
| S021 | 2010-10-12 | 30-day Notice |
| S020 | 2010-10-01 | 30-day Notice |
| S019 | 2010-02-26 | Normal 180 Day Track No User Fee |
| S018 | 2010-01-04 | Normal 180 Day Track |
| S017 | 2009-11-17 | Real-time Process |
| S016 | 2009-07-01 | Normal 180 Day Track No User Fee |
| S015 | 2008-09-03 | 30-day Notice |
| S014 | 2008-08-22 | 30-day Notice |
| S013 | 2008-04-10 | 30-day Notice |
| S012 | 2007-03-30 | Special (immediate Track) |
| S011 | 2006-03-08 | 30-day Notice |
| S010 | 2005-12-12 | 30-day Notice |
| S009 | 2005-12-09 | 30-day Notice |
| S008 | 2005-09-12 | Normal 180 Day Track No User Fee |
| S007 | 2005-07-28 | 30-day Notice |
| S006 | 2005-06-17 | 30-day Notice |
| S005 | 2005-05-04 | 30-day Notice |
| S004 | 2005-04-04 | 30-day Notice |
| S003 | 2003-07-23 | Real-time Process |
| S002 | 2002-04-16 | Normal 180 Day Track |
| S001 | 2001-09-07 | Panel Track |