Alto Abdominal Stent Graft System
FDA premarket approval P120006/S031 · decided 2020-03-13
Approval details
- PMA number
- P120006
- Supplement
- S031
- Supplement type
- Panel Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Alto Abdominal Stent Graft System
- Generic name
- SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
- Applicant
- Endologix, LLC
- Date received
- 2019-03-13
- Decision date
- 2020-03-13
- Days to decision
- 366 days
- Decision code
- APPR
- Product code
- MIH
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Rosa, CA
- Statement
- Approval for the Alto Abdominal Stent Graft System. The device is indicated for treatment of patients with infrarenal abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair with the device, which includes the following:1) Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories;2) A proximal aortic landing zone for the sealing ring 7mm below the inferior renal artery; 3) An aortic s
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