PMA P040002S040
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S040
- Product code
- MIH
- Decision date
- 2012-12-28
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE ADDITION OF BIFURCATED STENT GRAFT MODELS FOR THE APPROVED AFX ENDOVASCULAR AAA SYSTEM PRODUCT FAMILY. THE NEW MODELS CONTAIN SHORTER AND LONGER BIFURCATED BODIES THAT WILL HAVE THE SAME DIAMETER AS THOSE CURRENTLY APPROVED; AND TO ADD 20MM DIAMETER LIMBS USING THE SAME STENT CAGE.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S040
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-12-28
- Decision code
- APPR
- Date received
- 2012-11-08
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF BIFURCATED STENT GRAFT MODELS FOR THE APPROVED AFX ENDOVASCULAR AAA SYSTEM PRODUCT FAMILY. THE NEW MODELS CONTAIN SHORTER AND LONGER BIFURCATED BODIES THAT WILL HAVE THE SAME DIAMETER AS THOSE CURRENTLY APPROVED; AND TO ADD 20MM DIAMETER LIMBS USING THE SAME STENT CAGE.