PMA P040002S023
- Device
- POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S023
- Product code
- MIH
- Decision date
- 2009-02-20
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL TO MOVE THE 34MM ACCESSORIES OVER TO INTUITRAK DELIVERY SYSTEM LINE AS WELL AS MAKING A STAND ALONE VERSION OF THE 34MM BIFURCATED BODY DELIVERY SHEATH AVAILABLE.
Current openFDA PMA Record#
- Device
- POWERLINK SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S023
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2009-02-20
- Decision code
- APPR
- Date received
- 2009-01-22
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO MOVE THE 34MM ACCESSORIES OVER TO INTUITRAK DELIVERY SYSTEM LINE AS WELL AS MAKING A STAND ALONE VERSION OF THE 34MM BIFURCATED BODY DELIVERY SHEATH AVAILABLE.