FDA.reportPublic FDA data

PMA P040002S054

Device
AFX ENDOVASCULAR AAA SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S054
Product code
MIH
Decision date
2015-06-17
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
APPROVAL FOR UPDATES TO THE AFX INSTRUCTIONS FOR USE TO CLARIFY EXISTINGINFORMATION RELATED TO PROCEDURE PLANNING AND FOLLOW-UP IMAGING, AND TO IMPROVE THE INSTRUCTIONS FOR DELIVERY SYSTEM WITHDRAWAL OF THE AFX VELA PROXIMAL ENDOGRAFT.

Current openFDA PMA Record#

Device
AFX ENDOVASCULAR AAA SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S054
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2015-06-17
Decision code
APPR
Date received
2015-05-19
Supplement type
Special (Immediate Track)
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
APPROVAL FOR UPDATES TO THE AFX INSTRUCTIONS FOR USE TO CLARIFY EXISTINGINFORMATION RELATED TO PROCEDURE PLANNING AND FOLLOW-UP IMAGING, AND TO IMPROVE THE INSTRUCTIONS FOR DELIVERY SYSTEM WITHDRAWAL OF THE AFX VELA PROXIMAL ENDOGRAFT.