System, Endovascular Graft, Aortic Aneurysm Treatment
Basic Information
- Device Name
- System, Endovascular Graft, Aortic Aneurysm Treatment
- Trade Name
- GORE EXCLUDER ILIAC BRANCH ENDOPROSTHESIS
- PMA Number
- P020004
- Supplement Number
- S123
- 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 29, 2016
- Date Received
- September 2, 2015
- Supplement Type
- Panel Track
- Supplement Reason
- Change Design/Components/Specifications/Material
- Expedited Review
- N
- Docket Number
- 16M-0928
Advisory Committee Statement
Approval for the GORE® EXCLUDER® Iliac Branch Endoprosthesis (IBE Device). This device is indicated for use with the GORE® EXCLUDER® AAA Endoprosthesis to isolate the common iliac artery from systemic blood flow and preserve blood flow in the external iliac and internal iliac arteries in patients with a common iliac or aortoiliac aneurysm, who have appropriate anatomy, including: 1) Adequate iliac/ femoral access; 2) Minimum common iliac diameter of 17 mm at the proximal implantation zone of the IBE; 3) External iliac artery treatment diameter range of 6.5 25 mm and seal zone length of at least 10 mm; 4) Internal iliac artery treatment diameter range of 6.5 13.5 mm and seal zone length of at least 10 mm; and 5) Adequate length from the lowest major renal artery to the internal iliac artery to accommodate the total endoprosthesis length, calculated by adding the minimum lengths of required components, taking into account appropriate overlaps between components.
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 |