FDA.reportPublic FDA data

PMA P040002S068

Device
AFX2 Endovascular AAA System
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S068
Product code
MIH
Decision date
2021-06-17
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
Supplier and manufacturing changes for the suture material used in the delivery system and in process manufacturing for the AFX Endovascular AAA System.

Current openFDA PMA Record#

Device
AFX2 Endovascular AAA System
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S068
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2021-06-17
Decision code
OK30
Date received
2021-05-19
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Supplier and manufacturing changes for the suture material used in the delivery system and in process manufacturing for the AFX Endovascular AAA System.