This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the ats open pivot bileaflet heart valve, standard aortic model a500fa 21, 23, 25, 27, and 29 mm, standard mitroal model 500dm 29, 31, and 33 mm, advanced performance (ap) aortic model 501da 18, 20, 22, 24, and 26 mm, and ap mitral model 510dm 26 and 28 mm. The device in indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic or mitral valves.
| Device | ATS OPEN PIVOT BILEAFLET HEART VALVE |
| Classification Name | Heart-valve, Mechanical |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDTRONIC ATS MEDICAL, INC. |
| Date Received | 1999-07-29 |
| Decision Date | 2000-10-13 |
| Notice Date | 2000-10-20 |
| PMA | P990046 |
| Supplement | S |
| Product Code | LWQ |
| Docket Number | 00M-1570 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC ATS MEDICAL, INC. 3800 Annapolis Lane, Suite 175 plymouth, MN 55447 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |