INCRAFT(R) AAA STENT GRAFT SYSTEM
FDA premarket approval P150002 · decided 2018-11-27
Approval details
- PMA number
- P150002
- Trade name
- INCRAFT(R) AAA STENT GRAFT SYSTEM
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Cordis US Corporation
- Date received
- 2015-01-15
- Decision date
- 2018-11-27
- Days to decision
- 1412 days
- Decision code
- APWD
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Miami Lakes, FL
- Statement
- Approval for the endovascular treatment of patients with infrarenal abdominal aortic aneurysms with the following characteristics:1) Adequate, but complex iliac or femoral vessel morphology (e.g., high tortuosity index, heavily calcified, small diameter), that is compatible with vascular access techniques, devices or accessories;2) Proximal neck length >= 10 mm;3) Aortic neck diameters >=17 mm and <= 31 mm;4) Aortic neck suitable for suprarenal fixation;5) Infrarenal and suprarenal neck angulati
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