PMA P040002S070

Device: AFX2 Endovascular AAA System
Applicant: Endologix, LLC
PMA number: P040002
Supplement: S070
Product code: MIH
Decision date: 2022-12-06
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: Approval for the updates to the AFX2 Endovascular AAA System labeling (i.e., Instructions For Use (IFU), patient guide, and implant card).

Current openFDA PMA Record#

Device: AFX2 Endovascular AAA System
Applicant: Endologix, LLC
PMA number: P040002
Supplement: S070
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2022-12-06
Decision code: APPR
Date received: 2022-03-15
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: Approval for the updates to the AFX2 Endovascular AAA System labeling (i.e., Instructions For Use (IFU), patient guide, and implant card).