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.
Endologix requested approval for updating the ifu with the following language:updating the ifu with the following language:“polymer leaks are a unique potential risk of the ovation device platform that have been reported post-market. The complications of polymer leakage in to the vasculature have ranged from transient hypotension to severe life-threatening anaphylactoid reactions, tissue necrosis and death. When polymer leaks occur, underfilling of the ovation ix sealing rings have led to intraoperative type ia endoleaks that have required additional therapy. The risk of polymer leak should be carefully considered along with the risks associated with alternative treatment options when making personalized treatment decisions for those individuals who fall within the indicated patient population as defined by the instructions for use. ” this updated language was agreed upon as part of the mitigation strategy of the class i recall of the ovation ix.
| Device | Ovation iX Abdominal Stent Graft System |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Endologix, Inc. |
| Date Received | 2020-06-09 |
| Decision Date | 2020-07-09 |
| PMA | P120006 |
| Supplement | S036 |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Endologix, 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 |