FDA.reportPublic FDA data

PMA P040002S060

Device
AFX Endovascular AAA System
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S060
Product code
MIH
Decision date
2018-07-03
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Approval for modifications to the Instructions for Use regarding general information for interventions through or re-interventions on an existing AFX device, as well as patient-tailored surveillance recommendations.

Current openFDA PMA Record#

Device
AFX Endovascular AAA System
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S060
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2018-07-03
Decision code
APPR
Date received
2018-04-02
Supplement type
Real-Time Process
Supplement reason
Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement
Approval for modifications to the Instructions for Use regarding general information for interventions through or re-interventions on an existing AFX device, as well as patient-tailored surveillance recommendations.