PMA P040002S041

Device: AFX ENDOVASCULAR AAA SYSTEM
Applicant: Endologix, LLC
PMA number: P040002
Supplement: S041
Product code: MIH
Decision date: 2013-06-17
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR THE ADDITION OF A RELEASE SLEEVE TO THE PROXIMAL EXTENSION ACCESSORY STENT GRAFT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX VELA PROXIMAL ENDOGRAFT SYSTEM.

Current openFDA PMA Record#

Device: AFX ENDOVASCULAR AAA SYSTEM
Applicant: Endologix, LLC
PMA number: P040002
Supplement: S041
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2013-06-17
Decision code: APPR
Date received: 2013-05-02
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE ADDITION OF A RELEASE SLEEVE TO THE PROXIMAL EXTENSION ACCESSORY STENT GRAFT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX VELA PROXIMAL ENDOGRAFT SYSTEM.