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 endovascular treatment of patients with infrarenal abdominal aortic aneurysms with the following characteristics:1) adequate, but complex iliac or femoral vessel morphology (e. G. , high tortuosity index, heavily calcified, small diameter), that is compatible with vascular access techniques, devices or accessories;2) proximal neck length >= 10 mm;3) aortic neck diameters >=17 mm and = 7 mm and = 128 mm.
| Device | INCRAFT(R) AAA STENT GRAFT SYSTEM |
| Classification Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | Cordis Corporation |
| Date Received | 2015-01-15 |
| Decision Date | 2018-11-27 |
| Notice Date | 2018-12-06 |
| PMA | P150002 |
| Supplement | S |
| Product Code | MIH |
| Docket Number | 18M-4580 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis Corporation 6500 Paseo Padre Pkwy fremont, CA 94555 |
| 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 |
|---|---|---|
| P150002 | Original Filing | |
| S010 | 2021-04-26 | 30-day Notice |
| S009 | ||
| S008 | 2020-03-31 | Normal 180 Day Track No User Fee |
| S007 | 2019-08-12 | 135 Review Track For 30-day Notice |
| S006 | 2019-07-22 | 30-day Notice |
| S005 | 2019-06-10 | 30-day Notice |
| S004 | 2019-05-24 | 30-day Notice |
| S003 | 2019-05-24 | 30-day Notice |
| S002 | 2019-05-01 | 30-day Notice |
| S001 | 2019-01-25 | Normal 180 Day Track No User Fee |