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 modifications to the stopcock value, which is being replaced by the california valve, and the new supplier for the valve. The device, as modified, will be marketed under the trade name ovation prime abdominal stent graft system and is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including:1) adequate iliac/femoral access compatible with vascular access techniques, devices, and/or accessories;2) non-aneurysmal proximal aortic neck:a) with a length of at least 7 mm proximal to the aneurysm;b) with an inner wall diameter of no less than 16 mm and no greater than 30 mm; and c) with an aortic angle of = 10 mm and
| Device | TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | TRIVASCULAR INC |
| Date Received | 2013-10-23 |
| Decision Date | 2013-12-13 |
| PMA | P120006 |
| Supplement | S007 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |