PMA P230023S008
- Device
- GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P230023
- Supplement
- S008
- Product code
- QZK
- Decision date
- 2025-06-05
- Classification
- Cardiovascular
- Generic name
- Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
- Approval order statement
- an additional nitinol ingot supplier
Current openFDA PMA Record#
- Device
- GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P230023
- Supplement
- S008
- Product code
- QZK
- Generic name
- Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
- Decision date
- 2025-06-05
- Decision code
- OK30
- Date received
- 2025-05-14
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- an additional nitinol ingot supplier