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 medtronic freestyle(r) aortic root bioprosthesis, model 995; sizes 19, 21, 23, 25, 27 mm; implantation techniqures, subcoronary, full-root, and root inclusion; and the freestyle(r) aortic obturators, model 7990 and the medtronic handle, model 0791. This device is a replacement heart valve and is indicated for the replacement of malfunctioning native or prosthetic aortic valves with the optio of aortic root replacement.
| 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 | 1997-07-14 |
| Decision Date | 1997-11-26 |
| PMA | P970031 |
| Supplement | S |
| Product Code | LWR |
| Docket Number | 98M-0906 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 1851 East Deere Ave. santa Ana, CA 92705 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |