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 addition of the freeflo tapared stent-grafts to the list of devices indicated for treating thoracic aortic dissections,
| Device | VALIANT THORACIC STENT GRAFT SYSTEM WITH CAPTIVIA DELIVERY SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Medtronic Vascular |
| Date Received | 2014-02-07 |
| Decision Date | 2014-04-30 |
| PMA | P100040 |
| Supplement | S017 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic Vascular 3576 Unocal Place santa Rosa, CA 95403 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100040 | Original Filing | |
| S055 | 2022-11-29 | 30-day Notice |
| S054 | 2022-11-18 | 30-day Notice |
| S053 | 2022-10-31 | 30-day Notice |
| S052 | 2022-09-27 | 30-day Notice |
| S051 | 2022-03-23 | 30-day Notice |
| S050 | 2021-11-30 | 30-day Notice |
| S049 | ||
| S048 | 2021-07-27 | 30-day Notice |
| S047 | 2021-04-23 | Special (immediate Track) |
| S046 | 2021-03-17 | 30-day Notice |
| S045 | 2021-03-04 | 30-day Notice |
| S044 | 2021-02-25 | 30-day Notice |
| S043 | ||
| S042 | ||
| S041 | 2020-09-04 | Normal 180 Day Track No User Fee |
| S040 | 2020-07-14 | 30-day Notice |
| S039 | 2019-09-17 | 30-day Notice |
| S038 | 2019-04-05 | 30-day Notice |
| S037 | 2018-09-24 | 30-day Notice |
| S036 | 2018-04-23 | Panel Track |
| S035 | 2018-04-05 | 30-day Notice |
| S034 | 2018-01-03 | 30-day Notice |
| S033 | 2017-11-20 | 30-day Notice |
| S032 | 2017-07-14 | 30-day Notice |
| S031 | 2017-04-19 | 30-day Notice |
| S030 | ||
| S029 | 2017-01-12 | 30-day Notice |
| S028 | 2016-08-17 | 135 Review Track For 30-day Notice |
| S027 | 2016-07-13 | 30-day Notice |
| S026 | 2016-06-29 | 30-day Notice |
| S025 | 2015-08-31 | 135 Review Track For 30-day Notice |
| S024 | 2015-08-07 | 30-day Notice |
| S023 | 2015-07-31 | 30-day Notice |
| S022 | 2015-05-26 | 30-day Notice |
| S021 | 2015-05-20 | Normal 180 Day Track No User Fee |
| S020 | 2015-03-20 | 135 Review Track For 30-day Notice |
| S019 | 2014-04-11 | 30-day Notice |
| S018 | ||
| S017 | 2014-02-07 | Real-time Process |
| S016 | 2014-01-31 | 30-day Notice |
| S015 | 2013-12-16 | 30-day Notice |
| S014 | 2013-11-15 | 30-day Notice |
| S013 | 2013-11-04 | Real-time Process |
| S012 | 2013-07-29 | Panel Track |
| S011 | 2013-04-04 | 30-day Notice |
| S010 | 2013-01-29 | 30-day Notice |
| S009 | 2012-08-24 | 30-day Notice |
| S008 | 2012-04-30 | Panel Track |
| S007 | 2012-03-22 | 135 Review Track For 30-day Notice |
| S006 | 2011-06-14 | 30-day Notice |
| S005 | 2011-04-27 | Normal 180 Day Track No User Fee |
| S004 | 2011-04-27 | 30-day Notice |
| S003 | 2011-04-26 | 30-day Notice |
| S002 | 2011-04-21 | 30-day Notice |
| S001 | 2011-04-05 | 30-day Notice |