PMA P040002S004

Device
ENDOLOGIX POWERLINK STENT GRAFT DELIVERY SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S004
Product code
MIH
Decision date
2006-04-14
Classification
System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement
APPROVAL FOR TWO NEW BIFURCATED BODY SIZES LISTED AS MODELS 25-16-120BL AND 28-16-120BL.

Current openFDA PMA Record#

Device
ENDOLOGIX POWERLINK STENT GRAFT DELIVERY SYSTEM
Applicant
Endologix, LLC
PMA number
P040002
Supplement
S004
Product code
MIH
Generic name
SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date
2006-04-14
Decision code
APPR
Date received
2006-02-21
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR TWO NEW BIFURCATED BODY SIZES LISTED AS MODELS 25-16-120BL AND 28-16-120BL.