PMA P040002S007

Device
ENDOLOGIX POWERLINK SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S007
Product code
MIH
Decision date
2006-11-01
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE CONTRALATERAL LIMB COVER/GUIDEWIRE ASSEMBLY.

Current openFDA PMA Record#

Device
ENDOLOGIX POWERLINK SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S007
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2006-11-01
Decision code
APPR
Date received
2006-09-29
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR MODIFICATIONS TO THE CONTRALATERAL LIMB COVER/GUIDEWIRE ASSEMBLY.