PMA P230023S005

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S005
Product code: QZK
Decision date: 2024-11-18
Classification: Cardiovascular
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
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 and packaging of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Aortic Component (implant and delivery system).

Current openFDA PMA Record#

Device: GORE® EXCLUDER® Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S005
Product code: QZK
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Decision date: 2024-11-18
Decision code: APPR
Date received: 2024-10-18
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 and packaging of the GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis Aortic Component (implant and delivery system).