PMA P020004S205

Device: GORE® EXCLUDER® AAA Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S205
Product code: MIH
Decision date: 2026-05-14
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval to remove a warning from the device labeling regarding lack of safety and effectiveness data on the use of your device in treatment of ruptured aneurysms, as well as a brief summary of the supportive data with regard to treatment of ruptured aneurysms.

Current openFDA PMA Record#

Device: GORE® EXCLUDER® AAA Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S205
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-05-14
Decision code: APPR
Date received: 2026-02-13
Supplement type: Real-Time Process
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval to remove a warning from the device labeling regarding lack of safety and effectiveness data on the use of your device in treatment of ruptured aneurysms, as well as a brief summary of the supportive data with regard to treatment of ruptured aneurysms.