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 change to the formulation of a detergent used to clean valve orifices and leaflets.
| Device | Medtronic Open Pivot Mechanical Valve (OPHV), Medtronic Open Pivot Aortic Valved Graft (AVG) |
| Generic Name | Heart-valve, Mechanical |
| Applicant | MEDTRONIC ATS MEDICAL, INC. |
| Date Received | 2021-06-21 |
| Decision Date | 2022-01-20 |
| PMA | P990046 |
| Supplement | S060 |
| Product Code | LWQ |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |