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.
Implementation of an update to the iliac stent graft sheath loading fixture configuration and a revision to the corresponding loading process instructions to include the updated fixture configuration; 2) implementation of the modified maximum loading force specification and in-sheath force specification of the ovation ix iliac limb stent graft; and3) implementation of the modified crimp diameter for the 14 mm ovation ix iliac stent graft.
| Device | OVATION ABDOMINAL STENT GRAFT SYSTEM PLATFORM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | TRIVASCULAR INC |
| Date Received | 2016-07-28 |
| Decision Date | 2016-08-24 |
| PMA | P120006 |
| Supplement | S026 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TRIVASCULAR INC 3910 Brickway Blvd santa Rosa, CA 95403 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P120006 | Original Filing | |
| S041 | 2022-12-02 | 30-day Notice |
| S040 | ||
| S039 | ||
| S038 | ||
| S037 | 2020-06-18 | Normal 180 Day Track No User Fee |
| S036 | 2020-06-09 | Special (immediate Track) |
| S035 | 2020-03-31 | Normal 180 Day Track No User Fee |
| S034 | 2020-03-25 | 30-day Notice |
| S033 | ||
| S032 | 2019-03-25 | 30-day Notice |
| S031 | ||
| S030 | 2018-02-09 | Real-time Process |
| S029 | 2017-08-07 | 30-day Notice |
| S028 | 2017-07-19 | Real-time Process |
| S027 | ||
| S026 | 2016-07-28 | 30-day Notice |
| S025 | 2016-07-20 | 30-day Notice |
| S024 | 2016-03-18 | Normal 180 Day Track No User Fee |
| S023 | 2016-02-22 | Real-time Process |
| S022 | ||
| S021 | 2015-07-10 | 30-day Notice |
| S020 | 2015-05-04 | Real-time Process |
| S019 | 2015-04-01 | Real-time Process |
| S018 | 2014-11-26 | 30-day Notice |
| S017 | 2014-10-21 | Real-time Process |
| S016 | 2014-10-29 | 30-day Notice |
| S015 | 2014-08-07 | Normal 180 Day Track |
| S014 | 2014-07-22 | Real-time Process |
| S013 | 2014-04-17 | 135 Review Track For 30-day Notice |
| S012 | ||
| S011 | 2014-02-24 | 30-day Notice |
| S010 | 2014-01-31 | Normal 180 Day Track |
| S009 | 2013-11-12 | Normal 180 Day Track |
| S008 | 2013-11-04 | Special (immediate Track) |
| S007 | 2013-10-23 | Real-time Process |
| S006 | 2013-08-26 | 30-day Notice |
| S005 | 2013-08-12 | 135 Review Track For 30-day Notice |
| S004 | 2013-06-27 | Normal 180 Day Track No User Fee |
| S003 | 2013-01-31 | Normal 180 Day Track No User Fee |
| S002 | ||
| S001 | 2012-10-24 | Real-time Process |