|
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 | S128 |
Date Received | 03/11/2016 |
Decision Date | 04/08/2016 |
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 two additional catheter part numbers on an existing GORE EXCLUDER AAA Endoprosthesis SIM-PULL catheter manufacturing line in Gore’s Phoenix facility. |