PMA P040002S038
- Device
- AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S038
- Product code
- MIH
- Decision date
- 2012-08-22
- Classification
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Approval order statement
- APPROVAL FOR STAND-ALONE DELIVERY SYSTEM FOR THE STRAIGHT AND TAPERED LIMB EXTENSION STENT GRAFTS AND FOR THE FLARED LIMB EXTENSIONS GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM AS AN ACCESSORY TO THE AFX AAA ENDOVASCULAR SYSTEM WHICH IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA.
Current openFDA PMA Record#
- Device
- AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM
- Applicant
- Endologix, LLC
- PMA number
- P040002
- Supplement
- S038
- Product code
- MIH
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Decision date
- 2012-08-22
- Decision code
- APPR
- Date received
- 2012-07-05
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR STAND-ALONE DELIVERY SYSTEM FOR THE STRAIGHT AND TAPERED LIMB EXTENSION STENT GRAFTS AND FOR THE FLARED LIMB EXTENSIONS GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM AS AN ACCESSORY TO THE AFX AAA ENDOVASCULAR SYSTEM WHICH IS INDICATED FOR ENDOVASCULAR TREATMENT IN PATIENTS WITH AAA.