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Device | 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 | S006 |
Date Received | 11/17/2021 |
Decision Date | 12/16/2021 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | 30-Day Notice |
Supplement Reason | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Add a manufacturing line for the Graft Attach and Stent Graft Crush manufacturing process for the GORE EXCLUDER Conformable AAA Endoprosthesis (EXCC) device. |