|
Device | Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch 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 | S172 |
Date Received | 12/09/2019 |
Decision Date | 12/20/2019 |
Product Code |
MIH |
Advisory Committee |
Cardiovascular |
Supplement Type | Special (Immediate Track) |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updates to the Instructions for Use. The updates include modifications to existing warning statements, addition of a new warning statement, addition of new procedural steps and recommended material, and addition of new adverse events that may occur and/or require reintervention or additional procedural time. |