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Device | Gore Excluder Conformable AAA Endoprosthesis (CEXC) |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W. L. Gore and Associates, Inc. 32360 N. North Valley Parkway Phoenix, AZ 85085 |
PMA Number | P200030 |
Date Received | 06/29/2020 |
Decision Date | 12/22/2020 |
Product Code |
MIH |
Docket Number | 20M-2339 |
Notice Date | 12/23/2020 |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02489539
|
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement 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:1) Adequate iliac / femoral access;2) Infrarenal aortic neck treatment diameter range of 16–32 mm;3) A minimum aortic neck length of 15 mm when proximal aortic neck angulation is =<60 degrees; and4) Iliac artery treatment diameter range of 8–25 mm and iliac distal vessel seal zone length of at least 10 mm. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 |