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.
Addition of batch set-up software used in the dimensional measurement process.
| Device | ON-X PROSTHETIC HEART VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | On-X Life Technologies, Inc. |
| Date Received | 2005-12-12 |
| Decision Date | 2006-01-10 |
| PMA | P000037 |
| Supplement | S010 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |