This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the relay thoracic stent-graft with plus delivery system. This device is indicated for the endovascular repair of fusiform aneurysms and saccular aneurysms/ penetrating atherosclerotic ulcers in the descending thoracic aorta in patients having appropriate anatomy, including: 1) iliac or femoral access vessel morphology that is compatible with vascular access techniques, devices and/or accessories; 2) non-aneurysmal aortic neck diameter in the range of 19 - 42 mm; and 3) non-aneurysmal proximal aortic neck lengths between 15 and 25 nun and distal aortic neck lengths between 25 and 30 mm depending on the diameter stent-graft required.
| Device | RELAY THORACIC STENT-GRAFT WITH PLUS DELIVERY SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | BOLTON MEDICAL, INC. |
| Date Received | 2011-11-04 |
| Decision Date | 2012-09-21 |
| Notice Date | 2012-10-02 |
| PMA | P110038 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 12M-1012 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | BOLTON MEDICAL, INC. 799 International Parkway sunrise, FL 33325 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P110038 | Original Filing | |
| S027 | 2022-12-23 | Special (immediate Track) |
| S026 | 2022-07-12 | 30-day Notice |
| S025 | 2020-11-24 | 30-day Notice |
| S024 | 2019-09-30 | 30-day Notice |
| S023 | 2019-03-20 | 30-day Notice |
| S022 | ||
| S021 | ||
| S020 | 2018-10-05 | 30-day Notice |
| S019 | ||
| S018 | 2018-05-17 | Special (immediate Track) |
| S017 | 2017-12-07 | Normal 180 Day Track No User Fee |
| S016 | 2017-11-17 | Special (immediate Track) |
| S015 | 2017-04-07 | 30-day Notice |
| S014 | 2016-09-16 | 30-day Notice |
| S013 | 2016-08-29 | 135 Review Track For 30-day Notice |
| S012 | 2016-06-21 | Real-time Process |
| S011 | 2016-02-22 | Real-time Process |
| S010 | 2015-10-19 | Special (immediate Track) |
| S009 | 2015-01-06 | Normal 180 Day Track No User Fee |
| S008 | 2014-11-14 | 30-day Notice |
| S007 | ||
| S006 | 2014-09-15 | 30-day Notice |
| S005 | 2014-05-12 | 30-day Notice |
| S004 | 2014-03-24 | 30-day Notice |
| S003 | ||
| S002 | 2013-06-10 | 30-day Notice |
| S001 | 2012-10-19 | Normal 180 Day Track No User Fee |