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 modification to the polypropylene resin material formulation used in the packaging lid and retainer assembly.
| Device | Freestyle Bioprosthesis |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | Medtronic, Inc. |
| Date Received | 2019-09-26 |
| Decision Date | 2019-12-10 |
| PMA | P970031 |
| Supplement | S067 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970031 | Original Filing | |
| S069 | 2020-11-19 | 30-day Notice |
| S068 | ||
| S067 | 2019-09-26 | Real-time Process |
| S066 | 2019-06-20 | 30-day Notice |
| S065 | 2019-01-29 | 30-day Notice |
| S064 | ||
| S063 | 2018-04-12 | 30-day Notice |
| S062 | 2017-12-20 | 30-day Notice |
| S061 | 2017-10-18 | 30-day Notice |
| S060 | ||
| S059 | 2017-09-11 | 30-day Notice |
| S058 | 2017-08-14 | 135 Review Track For 30-day Notice |
| S057 | 2017-07-10 | 30-day Notice |
| S056 | 2017-02-22 | 30-day Notice |
| S055 | 2017-02-08 | 30-day Notice |
| S054 | 2016-11-10 | Real-time Process |
| S053 | 2016-10-25 | 30-day Notice |
| S052 | 2016-05-06 | 30-day Notice |
| S051 | 2015-10-13 | 30-day Notice |
| S050 | 2015-09-21 | Special (immediate Track) |
| S049 | 2014-11-07 | 30-day Notice |
| S048 | 2014-10-14 | 30-day Notice |
| S047 | 2014-08-05 | 30-day Notice |
| S046 | 2014-06-23 | 30-day Notice |
| S045 | 2014-04-23 | 30-day Notice |
| S044 | 2013-09-17 | 30-day Notice |
| S043 | 2013-07-01 | 30-day Notice |
| S042 | 2013-04-02 | 135 Review Track For 30-day Notice |
| S041 | 2013-04-01 | 135 Review Track For 30-day Notice |
| S040 | 2013-04-01 | 30-day Notice |
| S039 | 2013-02-13 | 30-day Notice |
| S038 | 2012-12-13 | 30-day Notice |
| S037 | 2012-11-19 | 30-day Notice |
| S036 | 2012-03-23 | Normal 180 Day Track |
| S035 | 2011-08-17 | 30-day Notice |
| S034 | 2011-07-28 | 30-day Notice |
| S033 | ||
| S032 | 2011-02-15 | Real-time Process |
| S031 | 2010-10-21 | 30-day Notice |
| S030 | 2010-10-20 | 30-day Notice |
| S029 | 2010-04-30 | 30-day Notice |
| S028 | 2010-01-06 | 30-day Notice |
| S027 | 2010-01-06 | 135 Review Track For 30-day Notice |
| S026 | 2009-10-05 | 30-day Notice |
| S025 | 2009-07-09 | 30-day Notice |
| S024 | 2008-08-11 | 30-day Notice |
| S023 | 2008-07-11 | 30-day Notice |
| S022 | 2007-10-15 | 30-day Notice |
| S021 | ||
| S020 | 2007-09-19 | 30-day Notice |
| S019 | 2007-07-02 | 135 Review Track For 30-day Notice |
| S018 | ||
| S017 | 2006-08-03 | 30-day Notice |
| S016 | ||
| S015 | 2006-03-27 | Normal 180 Day Track No User Fee |
| S014 | 2005-12-27 | 135 Review Track For 30-day Notice |
| S013 | 2003-07-28 | Normal 180 Day Track |
| S012 | ||
| S011 | 2001-06-01 | Normal 180 Day Track |
| S010 | 2001-05-03 | Normal 180 Day Track |
| S009 | 1999-08-30 | Normal 180 Day Track |
| S008 | 1999-08-04 | Normal 180 Day Track |
| S007 | 1998-10-02 | 30-day Notice |
| S006 | 1998-04-06 | Normal 180 Day Track |
| S005 | 1998-02-11 | Normal 180 Day Track |
| S004 | 1998-01-12 | Normal 180 Day Track |
| S003 | 1997-12-24 | Normal 180 Day Track |
| S002 | ||
| S001 |