PMA P040002S053
- Device
- AFX VELA PROXIMAL ENDOGRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S053
- Product code
- MIH
- Decision date
- 2014-08-12
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR AN ADDITIONAL IN PROCESS X-RAY INSPECTION STEP.
Current openFDA PMA Record#
- Device
- AFX VELA PROXIMAL ENDOGRAFT SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S053
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2014-08-12
- Decision code
- APPR
- Date received
- 2014-07-16
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- APPROVAL FOR AN ADDITIONAL IN PROCESS X-RAY INSPECTION STEP.