PMA P230023S006

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S006
Product code: QZK
Decision date: 2025-05-20
Classification: Cardiovascular
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Approval order statement: use of the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component option for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)

Current openFDA PMA Record#

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S006
Product code: QZK
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Decision date: 2025-05-20
Decision code: APPR
Date received: 2024-11-22
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: use of the Reduced Profile GORE VIABAHN VBX Balloon Expandable Endoprosthesis as a branch component option for the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis (TAMBE)