PMA P040002S014
- Device
- POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S014
- Product code
- MIH
- Decision date
- 2008-03-05
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE STEEL HYPOTUBE FROM THE 21FR BIFURCATED DELIVERY SYSTEM, THE 17FR STRAIGHT DELIVERY SYSTEM, AND THE 19FR DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM WITH VISIFLEX DELIVERY CATHETER
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S014
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-03-05
- Decision code
- APPR
- Date received
- 2007-12-26
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE REMOVAL OF THE STEEL HYPOTUBE FROM THE 21FR BIFURCATED DELIVERY SYSTEM, THE 17FR STRAIGHT DELIVERY SYSTEM, AND THE 19FR DELIVERY SYSTEM.