PMA P230023S007

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S007
Product code: QZK
Decision date: 2025-01-03
Classification: Cardiovascular
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Approval order statement: a change to the manufacturing process for the leading olive component of the delivery system of Gore TAMBE

Current openFDA PMA Record#

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S007
Product code: QZK
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Decision date: 2025-01-03
Decision code: OK30
Date received: 2025-01-02
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: a change to the manufacturing process for the leading olive component of the delivery system of Gore TAMBE