FDA.reportPublic FDA data

PMA P040002S061

Device
AFX Endovascular AAA System
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S061
Product code
MIH
Decision date
2018-08-09
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for modifications to the AFX System Instructions for Use, specifically the inclusion of a sizing algorithm and clarification on device sizing guidelines.

Current openFDA PMA Record#

Device
AFX Endovascular AAA System
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S061
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2018-08-09
Decision code
APPR
Date received
2018-07-10
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for modifications to the AFX System Instructions for Use, specifically the inclusion of a sizing algorithm and clarification on device sizing guidelines.