PMA P210032S015

Device: GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
Applicant: W. L. Gore & Associates, Inc.
PMA number: P210032
Supplement: S015
Product code: SDZ
Decision date: 2025-04-11
Classification: Cardiovascular
Generic name: Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
Approval order statement: Approval for the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) for expanding the indications to include treatment of lesions of the aortic arch. This device is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel, in patients with appropriate anatomy.

Current openFDA PMA Record#

Device: GORE TAG Thoracic Branch Endoprosthesis (TBE Device)
Applicant: W. L. Gore & Associates, Inc.
PMA number: P210032
Supplement: S015
Product code: SDZ
Generic name: Endovascular System for Treatment of Ascending Aorta and Aortic Arch Lesions
Decision date: 2025-04-11
Decision code: APPR
Date received: 2024-08-26
Supplement type: Panel Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the GORE TAG Thoracic Branch Endoprosthesis (TBE Device) for expanding the indications to include treatment of lesions of the aortic arch. This device is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel, in patients with appropriate anatomy.