PMA P040002S005
- Device
- ENDOLOGIX POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S005
- Product code
- MIH
- Decision date
- 2006-05-17
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR A NEW VERSION OF THE VISIFLEX DELIVERY CATHETER FOR BOTH THE BIFURCATED AND STRAIGHT STENT GRAFTS.
Current openFDA PMA Record#
- Device
- ENDOLOGIX POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S005
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2006-05-17
- Decision code
- APPR
- Date received
- 2006-03-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A NEW VERSION OF THE VISIFLEX DELIVERY CATHETER FOR BOTH THE BIFURCATED AND STRAIGHT STENT GRAFTS.