PMA P020004S206

Device: GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S206
Product code: MIH
Decision date: 2026-04-28
Classification: Cardiovascular
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Addition of secondary manufacturing line for bonding process of Iliac Branch Component Trunk and Low-Profile Aortic SIM-PULL catheters.

Current openFDA PMA Record#

Device: GORE® EXCLUDER® AAA Endoprosthesis; GORE® EXCLUDER® Iliac Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S206
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2026-04-28
Decision code: OK30
Date received: 2026-03-30
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Addition of secondary manufacturing line for bonding process of Iliac Branch Component Trunk and Low-Profile Aortic SIM-PULL catheters.