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 a modified aortic sewing cuff as an extension to the line of available valves; the request applied to the aortic sizes 19, 21, 23, 25, and 27/29 mm. The device, as modified, will be marketed under the trade name on-x conform-x aortic prosthetic heart valve and will be given the model designation of model onxac and is indicated for replacement of diseased, damaged, or malfunctioning native or prosthetic heart valves in the aortic position.
| Device | ON-X CONFORM-X AORTIC PROSTHETIC HEART VALVE, MODEL ONXAC |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | On-X Life Technologies, Inc. |
| Date Received | 2002-04-16 |
| Decision Date | 2002-10-11 |
| PMA | P000037 |
| Supplement | S002 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |