PMA P040043S132

Device: GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S132
Product code: MIH
Decision date: 2023-01-12
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for implementation of updates to the warnings and MR compatibility information in the Instructions for Use (IFU) and patient implant card.

Current openFDA PMA Record#

Device: GORE TAG Conformable Thoracic Endoprosthesis, GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System
Applicant: W. L. Gore & Associates, Inc.
PMA number: P040043
Supplement: S132
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2023-01-12
Decision code: APPR
Date received: 2022-12-15
Supplement type: Special (Immediate Track)
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for implementation of updates to the warnings and MR compatibility information in the Instructions for Use (IFU) and patient implant card.