PMA P040002S032

Device
POWERLINK WITH INTUITRAK DELIVERY SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S032
Product code
MIH
Decision date
2011-06-30
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
ALTERNATE SUPPLIER OF SUTURE MATERIAL.

Current openFDA PMA Record#

Device
POWERLINK WITH INTUITRAK DELIVERY SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S032
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2011-06-30
Decision code
OK30
Date received
2011-05-31
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ALTERNATE SUPPLIER OF SUTURE MATERIAL.