PMA P040002S022

Device
POWERLINK SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S022
Product code
MIH
Decision date
2009-04-17
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
APPROVAL FOR THE 25MM AND 28MM SUPRARENAL CUFF ACCESSORIES FOR THE INFRARENAL VERSION OF THE POWERLINK BIFURCATED STENT GRAFT.

Current openFDA PMA Record#

Device
POWERLINK SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S022
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2009-04-17
Decision code
APPR
Date received
2008-10-06
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE 25MM AND 28MM SUPRARENAL CUFF ACCESSORIES FOR THE INFRARENAL VERSION OF THE POWERLINK BIFURCATED STENT GRAFT.