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 to combine the ats open pivot bileaflet heart valve (approved on october 13, 2000 under p990046) with the meadox hemashield woven double velour vascular graft (approved on may 11, 1993 under p840029/s005). The device, as modified, will be marketed under the trade name ats open pivot bileaflet aortic valved graft, models 502ag21 through 502ag29, and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves, where a replacement valve and replacement or repair of the aorta is required.
| Device | ATS OPEN PIVOT BILEAFLET AORTIC VALVED GRAFT |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDTRONIC ATS MEDICAL, INC. |
| Date Received | 2001-09-24 |
| Decision Date | 2002-06-07 |
| PMA | P990046 |
| Supplement | S005 |
| 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 | MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Lane, Suite 175 plymouth, MN 55447 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P990046 | Original Filing | |
| S065 | 2022-09-26 | 30-day Notice |
| S064 | 2022-03-07 | 30-day Notice |
| S063 | 2022-03-04 | 30-day Notice |
| S062 | 2022-02-08 | 30-day Notice |
| S061 | ||
| S060 | 2021-06-21 | 135 Review Track For 30-day Notice |
| S059 | 2021-05-06 | Real-time Process |
| S058 | 2021-03-24 | 30-day Notice |
| S057 | 2020-02-24 | 30-day Notice |
| S056 | 2020-02-20 | 30-day Notice |
| S055 | ||
| S054 | 2018-06-22 | 30-day Notice |
| S053 | ||
| S052 | 2017-10-23 | 30-day Notice |
| S051 | 2017-09-07 | 30-day Notice |
| S050 | 2017-08-14 | 135 Review Track For 30-day Notice |
| S049 | 2017-07-26 | 30-day Notice |
| S048 | 2016-11-07 | 30-day Notice |
| S047 | 2016-07-11 | 30-day Notice |
| S046 | 2016-02-18 | 30-day Notice |
| S045 | 2016-02-10 | 30-day Notice |
| S044 | 2015-11-24 | 30-day Notice |
| S043 | 2015-11-16 | 30-day Notice |
| S042 | 2015-10-30 | Real-time Process |
| S041 | 2015-08-10 | 135 Review Track For 30-day Notice |
| S040 | 2015-03-27 | 30-day Notice |
| S039 | 2014-10-14 | 30-day Notice |
| S038 | 2014-07-25 | 30-day Notice |
| S037 | 2013-12-26 | 30-day Notice |
| S036 | 2013-09-10 | 30-day Notice |
| S035 | 2013-07-08 | 30-day Notice |
| S034 | 2013-07-01 | Special (immediate Track) |
| S033 | 2013-06-26 | 30-day Notice |
| S032 | 2013-03-28 | Normal 180 Day Track No User Fee |
| S031 | 2013-03-01 | 30-day Notice |
| S030 | 2012-10-23 | 30-day Notice |
| S029 | 2012-04-26 | Normal 180 Day Track No User Fee |
| S028 | 2012-03-23 | Normal 180 Day Track No User Fee |
| S027 | 2012-03-08 | Special (immediate Track) |
| S026 | 2011-12-13 | Normal 180 Day Track No User Fee |
| S025 | 2011-10-25 | 30-day Notice |
| S024 | ||
| S023 | ||
| S022 | 2010-07-12 | Special (immediate Track) |
| S021 | 2009-04-23 | 30-day Notice |
| S020 | 2009-03-13 | 30-day Notice |
| S019 | 2008-09-26 | Normal 180 Day Track No User Fee |
| S018 | 2007-11-28 | 135 Review Track For 30-day Notice |
| S017 | 2007-01-30 | Real-time Process |
| S016 | 2006-12-15 | Normal 180 Day Track |
| S015 | ||
| S014 | 2005-04-07 | 135 Review Track For 30-day Notice |
| S013 | 2004-09-01 | Normal 180 Day Track |
| S012 | ||
| S011 | 2004-04-27 | Real-time Process |
| S010 | 2004-01-30 | 30-day Notice |
| S009 | 2003-08-28 | 30-day Notice |
| S008 | 2003-08-19 | 30-day Notice |
| S007 | 2003-05-20 | Real-time Process |
| S006 | 2002-05-01 | Normal 180 Day Track |
| S005 | 2001-09-24 | Normal 180 Day Track |
| S004 | 2001-03-26 | Normal 180 Day Track |
| S003 | 2000-10-20 | Normal 180 Day Track |
| S002 | ||
| S001 | 2000-10-17 | Normal 180 Day Track |