PMA P040002S025

Device: POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM
Applicant: Endologix, LLC
PMA number: P040002
Supplement: S025
Product code: MIH
Decision date: 2009-09-16
Classification: System, Endovascular Graft, Aortic Aneurysm Treatment
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Approval order statement: APPROVAL FOR CHANGES MADE TO THE LABELING TO INCLUDE INSTRUCTIONS FOR THE OPTION OF DEPLOYING OF THE IPSILATERAL LEG FIRST.

Current openFDA PMA Record#

Device: POWERLINK SYSTEM WITH INTUI TRAK DELIVERY SYSTEM
Applicant: Endologix, LLC
PMA number: P040002
Supplement: S025
Product code: MIH
Generic name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
Decision date: 2009-09-16
Decision code: APPR
Date received: 2009-09-01
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR CHANGES MADE TO THE LABELING TO INCLUDE INSTRUCTIONS FOR THE OPTION OF DEPLOYING OF THE IPSILATERAL LEG FIRST.