|
Device | GORE®1 EXCLUDER® Conformable AAA Endoprosthesis (CEXC), GORE® EXCLUDER® Conformable AAA Endoprosthesis (EXCC) |
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 |
Supplement Number | S014 |
Date Received | 10/10/2023 |
Decision Date | 04/05/2024 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT02489539
|
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for expanding the indications for use |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |