PMA P020004S204
- Device
- GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S204
- Product code
- MIH
- Decision date
- 2025-10-09
- Classification
- Cardiovascular
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- changes to equipment used in the manufacturing process of the SIM-PULL delivery system
Current openFDA PMA Record#
- Device
- GORE® EXCLUDER® AAA Endoprosthesis and Iliac Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P020004
- Supplement
- S204
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2025-10-09
- Decision code
- OK30
- Date received
- 2025-09-12
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- changes to equipment used in the manufacturing process of the SIM-PULL delivery system