PMA P020004S193

Device: GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S193
Product code: MIH
Decision date: 2022-11-18
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of an external supplier for the extruded catheter components of the GORE EXCLUDER AAA Endoprosthesis and GORE EXCLUDER Iliac Branch Endoprosthesis.

Current openFDA PMA Record#

Device: GORE® EXCLUDER® AAA Endoprosthesis, GORE® EXCLUDER® Iliac Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S193
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-11-18
Decision code: OK30
Date received: 2022-10-21
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of an external supplier for the extruded catheter components of the GORE EXCLUDER AAA Endoprosthesis and GORE EXCLUDER Iliac Branch Endoprosthesis.