PMA P230023S010

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S010
Product code: QZK
Decision date: 2026-01-15
Classification: Cardiovascular
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230023.

Current openFDA PMA Record#

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S010
Product code: QZK
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Decision date: 2026-01-15
Decision code: APPR
Date received: 2025-08-15
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P230023.