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 the to add a larger diameter iliac limb and iliac extension, a longerlength iliac limb, and decrease the delivery system profile for each iliac limb and iliac extensions. The device, as modified, will be marketed under the trade name ovation primeabdominal stent graft system with the ovation ix iliac stent graft and is indicated for thetreatment of patients with abdominal aortic aneurysms having the vascular morphology suitablefor endovascular repair, including:1) adequateiliac/femoral access compatible with vascular access techniques (femoralcutdown or percutaneous), devices and/or accessories;2) proximal aortic landing zone:a) with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13mm below the inferior renal artery, and b) with an aortic angle of < 60 degrees if proximal neck is 10 ¿ mm degrees if proximal neck is < 10 mm; and 3) distal iliac landing zone:a) with a length of at least 10 mm, andb) with an inner wall diameter of no less than 8 mm and no greater than 25 mm.
| Device | TRIVASCULAR, INC OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM, TRIVASCULAR, INC OVATION IX ILIAC STENT GRAFT |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | TRIVASCULAR INC |
| Date Received | 2014-08-07 |
| Decision Date | 2015-02-02 |
| PMA | P120006 |
| Supplement | S015 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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 |