- Device
- Gore Excluder AAA Endoprosthesis and Gore Excluder Iliac Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S172
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2019-12-20
- Decision code
- APPR
- Date received
- 2019-12-09
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- 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.