|
Device | Gore Excluder AAA Endoprosthesis |
Generic Name | SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT |
Applicant | W.L. GORE & ASSOCIATES,INC 32360 N. North Valley Parkway Phoenix, AZ 85085 |
PMA Number | P020004 |
Supplement Number | S167 |
Date Received | 08/15/2019 |
Decision Date | 12/09/2019 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for the Gore Excluder AAA Trunk component to adopt the packaging system used for the Gore Excluder Thoracoabdominal Branch Endoprosthesis. |