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 freestyle aortic root bioprosthesis, model 995, size 29 mm; implantation techniques, subcoronary, full-root, and root inclusion. The supplement requested approval of this size as an addition to the existing, approved product line of sizes 19, 21, 23, 25, and 27 mm. The device is indicated for the replacement of malfunctioning native or prosthestic aortic valves with the option 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 | 2001-06-01 |
| Decision Date | 2001-11-16 |
| PMA | P970031 |
| Supplement | S011 |
| Product Code | LWR |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |