PMA P230023S004

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S004
Product code: QZK
Decision date: 2024-12-23
Classification: Cardiovascular
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Approval order statement: addition of color additives to the secondary sleeve deployment line, primary sleeve deployment line and sleeve attachment fibers of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis

Current openFDA PMA Record#

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S004
Product code: QZK
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Decision date: 2024-12-23
Decision code: APPR
Date received: 2024-09-30
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: addition of color additives to the secondary sleeve deployment line, primary sleeve deployment line and sleeve attachment fibers of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis