PMA P020004S190

Device: GORE(R) EXCLUDER(R) AAA Endoprosthesis, GORE(R) EXCLUDER(R) Iliac Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S190
Product code: MIH
Decision date: 2022-08-31
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Implementation of updates to the Radio Frequency bonding equipment used in the manufacturing of the GORE Excluder AAA and Iliac Branch Endoprostheses.

Current openFDA PMA Record#

Device: GORE(R) EXCLUDER(R) AAA Endoprosthesis, GORE(R) EXCLUDER(R) Iliac Branch Endoprosthesis
Applicant: W. L. Gore & Associates, Inc.
PMA number: P020004
Supplement: S190
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-08-31
Decision code: OK30
Date received: 2022-08-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Implementation of updates to the Radio Frequency bonding equipment used in the manufacturing of the GORE Excluder AAA and Iliac Branch Endoprostheses.