AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM
FDA premarket approval P040002/S038 · decided 2012-08-22
Approval details
- PMA number
- P040002
- Supplement
- S038
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFX STAND-ALONE LIMB EXTENSION DELIVERY SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2012-07-05
- Decision date
- 2012-08-22
- Days to decision
- 48 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- 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.
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