PMA P230023S002

Device: GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P230023
Supplement: S002
Product code: QZK
Decision date: 2024-06-21
Classification: Cardiovascular
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Approval order statement: approval of the revised protocol and Informed Consent Form 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: S002
Product code: QZK
Generic name: Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions
Decision date: 2024-06-21
Decision code: APPR
Date received: 2024-05-23
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval of the revised protocol and Informed Consent Form 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.