AFX ENDOVASCULAR AAA SYSTEM
FDA premarket approval P040002/S041 · decided 2013-06-17
Approval details
- PMA number
- P040002
- Supplement
- S041
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- AFX ENDOVASCULAR AAA SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2013-05-02
- Decision date
- 2013-06-17
- Days to decision
- 46 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Irvine, CA
- Statement
- APPROVAL FOR THE ADDITION OF A RELEASE SLEEVE TO THE PROXIMAL EXTENSION ACCESSORY STENT GRAFT DELIVERY SYSTEM. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AFX VELA PROXIMAL ENDOGRAFT SYSTEM.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.