PMA P020004S173

Device
Gore Excluder AAA Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P020004
Supplement
S173
Product code
MIH
Decision date
2020-03-04
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Update the trunk component specifications.

Current openFDA PMA Record#

Device
Gore Excluder AAA Endoprosthesis
Applicant
W. L. Gore & Associates, Inc.
PMA number
P020004
Supplement
S173
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2020-03-04
Decision code
OK30
Date received
2020-02-03
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update the trunk component specifications.