PMA P040002S044
- Device
- AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S044
- Product code
- MIH
- Decision date
- 2014-01-24
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR DIMENSIONAL MODIFICATION OF THE INNER CORE OF THE AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM.
Current openFDA PMA Record#
- Device
- AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S044
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-01-24
- Decision code
- APPR
- Date received
- 2013-11-12
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DIMENSIONAL MODIFICATION OF THE INNER CORE OF THE AFX VELA PROXIMAL ENDOGRAFT DELIVERY SYSTEM.