PMA P040002S017
- Device
- POWERLINK SYSTEM VISIFLEX IS DELIVERY CATHETERS
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S017
- Product code
- MIH
- Decision date
- 2008-06-12
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE NEW VISIFLEX IS BIFURCATED AND STRAIGHT DELIVERY CATHETERS.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM VISIFLEX IS DELIVERY CATHETERS
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S017
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2008-06-12
- Decision code
- APPR
- Date received
- 2008-04-11
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE NEW VISIFLEX IS BIFURCATED AND STRAIGHT DELIVERY CATHETERS.