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 manufacturing sites located at synergy health ast, llc, 9020 activity road suite d, san diego, california 92126 and synergy health ast, llc, 3200 lakeville highway, suite 120, petaluma, california 94954, for e-beam sterilization of the ovation abdominal stent graft system platform.
| Device | OVATION 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 | 2016-03-18 |
| Decision Date | 2016-09-29 |
| PMA | P120006 |
| Supplement | S024 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Location 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 |