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 the protocols to be used for the short term and long term post approval studies.
| Device | MEDTRONIC FREESTYLE AORTIC ROOT BIOPROSTHESIS |
| Classification Name | Heart-valve, Non-allograft Tissue |
| Generic Name | Heart-valve, Non-allograft Tissue |
| Applicant | Medtronic, Inc. |
| Date Received | 1998-01-12 |
| Decision Date | 1998-09-18 |
| PMA | P970031 |
| Supplement | S004 |
| Product Code | LWR |
| Docket Number | N |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| 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 |