FDA.reportPublic FDA data

PMA P020004S176

Device
GORE EXCLUDER AAA Endoprosthesis, GORE EXCLUDER Iliac Branch Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P020004
Supplement
S176
Product code
MIH
Decision date
2020-09-16
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Implementation of a manufacturing aid fixture, constraining sleeve manufacturing process reorder, additional instructions and an additional inspection in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis and the 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
S176
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-09-16
Decision code
OK30
Date received
2020-08-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Implementation of a manufacturing aid fixture, constraining sleeve manufacturing process reorder, additional instructions and an additional inspection in the manufacturing of the GORE EXCLUDER AAA Endoprosthesis and the GORE EXCLUDER Iliac Branch Endoprosthesis.