- Device
- GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
- Applicant
- W. L. Gore & Associates, Inc.
- PMA number
- P230023
- Supplement
- S003
- Product code
- QZK
- Generic name
- Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
- Decision date
- 2024-08-13
- Decision code
- APPR
- Date received
- 2024-06-13
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Location Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval for a manufacturing site W. L. Gore & Associates, Inc. located at 32360 N. North Valley Pkwy Phoenix AZ, 85085-4228 for manufacture of the endoprosthesis sub-assembly