PMA P040043S096

Device: Gore Tag Thoracic Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S096
Product code: MIH
Decision date: 2017-10-31
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for updates to the Gore CTAG Thoracic Endoprosthesis Instructions for Use (IFU), including additional language in the Warnings and Precautions and Patient Counseling sections.

Current openFDA PMA Record#

Device: Gore Tag Thoracic Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S096
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2017-10-31
Decision code: APPR
Date received: 2017-10-02
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for updates to the Gore CTAG Thoracic Endoprosthesis Instructions for Use (IFU), including additional language in the Warnings and Precautions and Patient Counseling sections.