PMA P040002S002

Device
POWERLINK SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S002
Product code
MIH
Decision date
2006-02-08
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
APPROVAL FOR A MANUFACTURING SITE IN IRVINE, CALIFORNIA.

Current openFDA PMA Record#

Device
POWERLINK SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S002
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2006-02-08
Decision code
APPR
Date received
2005-11-10
Supplement type
Normal 180 Day Track No User Fee
Supplement reason
Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
APPROVAL FOR A MANUFACTURING SITE IN IRVINE, CALIFORNIA.