|
Device | 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 | S159 |
Date Received | 09/26/2018 |
Decision Date | 10/24/2018 |
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 Implementation of a new film wrapping machine for use in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis and GORE EXCLUDER AAA Endoprosthesis. |