Approval for gore excluder conformable aaa endoprosthesis (excc)this device is indicated to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm (aaa) disease and who have appropriate anatomy as described below:• adequate iliac / femoral access• infrarenal aortic neck treatment diameter range of 16–32 mm• a minimum aortic neck length of 15 mm when proximal aortic neck angulation is? 60? • iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm.
| Device | Gore Excluder Conformable AAA Endoprosthesis (CEXC) |
| Generic Name | System, Endovascular Graft, Aortic Aneurysm Treatment |
| Applicant | W. L. Gore And Associates, Inc. |
| Date Received | 2020-06-29 |
| Decision Date | 2020-12-22 |
| PMA | P200030 |
| Supplement | S |
| Product Code | MIH |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | W. L. Gore And Associates, Inc. 32360 N. North Valley Parkway phoenix, AZ 85085 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P200030 | Original Filing | |
| S010 | 2022-09-06 | 30-day Notice |
| S009 | 2022-08-03 | 30-day Notice |
| S008 | 2022-06-28 | 30-day Notice |
| S007 | 2022-01-20 | 30-day Notice |
| S006 | 2021-11-17 | 30-day Notice |
| S005 | 2021-10-29 | 30-day Notice |
| S004 | 2021-09-07 | 30-day Notice |
| S003 | 2021-05-10 | 30-day Notice |
| S002 | 2021-04-06 | 30-day Notice |
| S001 | 2021-01-22 | 30-day Notice |
| Device ID | PMA | Supp |
|---|---|---|
| 00733132651078 | P200030 | 000 |
| 00733132650934 | P200030 | 000 |
| 00733132650941 | P200030 | 000 |
| 00733132650958 | P200030 | 000 |
| 00733132650965 | P200030 | 000 |
| 00733132650972 | P200030 | 000 |
| 00733132650989 | P200030 | 000 |
| 00733132650996 | P200030 | 000 |
| 00733132651009 | P200030 | 000 |
| 00733132651016 | P200030 | 000 |
| 00733132651023 | P200030 | 000 |
| 00733132651030 | P200030 | 000 |
| 00733132651047 | P200030 | 000 |
| 00733132651054 | P200030 | 000 |
| 00733132651061 | P200030 | 000 |
| 00733132650927 | P200030 | 000 |