System, Endovascular Graft, Aortic Aneurysm Treatment
Basic Information
- Device Name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Trade Name
- AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE
- PMA Number
- P110032
- Supplement Number
- S010
- Device Class
- FDA Class 3
- Product Code
- MIH
- Generic Name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- February 3, 2015
- Date Received
- November 7, 2014
- Supplement Type
- Real-Time Process
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
Advisory Committee Statement
APPROVAL FOR A LINE EXTENSION THAT WOULD INCLUDE TWO LARGER SIZE STENT GRAFTS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AORFIX AND AORFIX PLUS AAA FLEXIBLE STENT GRAFT SYSTEM WITH AORFLEX DELIVERY DEVICE AND IS INDICATED FOR TREATMENT OF PATIENTS WITH ABDOMINAL AORTIC AND AORTO-ILIAC ANEURYSMS HAVING VASCULAR MORPHOLOGY SUITABLE FOR ENDOVASCULAR REPAIR, INCLUDING: 1) ADEQUATE ILIAC OR FEMORAL ACCESS THAT IS COMPATIBLE WITH VASCULAR ACCESS TECHNIQUES, IMPLANTS, AND ACCESSORIES.2) AORTIC NECK LANDING ZONE DIAMETERS WITH A RANGE OF 19 MM TO 33 MM. 3) NON ANEURYSMAL PROXIMAL NECK CENTER-LINE LENGTH OF > 15 MM. 4) INFRARENAL AORTIC NECK ANGULATIONS INCLUDING THOSE UP TO AND INCLUDING 90°. 5) COMMON ILIAC LANDING ZONE DIAMETERS WITH A RANGE OF 9MM TO 19MM. 6) DISTAL FIXATION LENGTH OF > 15 MM.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MIH | System, Endovascular Graft, Aortic Aneurysm Treatment | FDA class 3 | Unknown |