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 updated in-process sampling requirements and to remove redundant inspections.
| 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 | 2016-08-17 |
| Decision Date | 2017-02-01 |
| PMA | P100040 |
| Supplement | S028 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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 |