PMA P040002S042
- Device
- AFX ENDOVASCULAR AAA DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S042
- Product code
- MIH
- Decision date
- 2013-08-26
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR THE ADDITION OF NEW GUIDEWIRE SUBASSEMBLY PROVIDED BY ACME MONACO.
Current openFDA PMA Record#
- Device
- AFX ENDOVASCULAR AAA DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S042
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2013-08-26
- Decision code
- APPR
- Date received
- 2013-07-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR THE ADDITION OF NEW GUIDEWIRE SUBASSEMBLY PROVIDED BY ACME MONACO.