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 changes to the inner packaging design and extension of the shelf life
| Device | Open Pivot Aortic Valved Graft |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDTRONIC ATS MEDICAL, INC. |
| Date Received | 2021-05-06 |
| Decision Date | 2021-07-29 |
| PMA | P990046 |
| Supplement | S059 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |