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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceAlto Abdominal Stent Graft System
Generic NameSYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
ApplicantEndologix, LLC
3910 Brickway Blvd
Santa Rosa, CA 95403
PMA NumberP120006
Supplement NumberS031
Date Received03/13/2019
Decision Date03/13/2020
Product Code MIH 
Docket Number 20M-1126
Notice Date 03/17/2020
Advisory Committee Cardiovascular
Clinical TrialsNCT02949297
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order 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 sealing zone comprised of healthy aorta defined as; a. Lack of significant thrombus > 8 mm in thickness; at any point along the aortic circumference at the level of 7mm below the inferior renal artery; b. Lack of significant calcification at the level of 7mm below the inferior renal artery; c. Conicity < 10% as measured from the inferior renal artery to the aorta 7mm below the inferior renal artery; d. An inner wall diameter of no less than 16 mm and no greater than 30 mm at 7 mm below the inferior renal artery; and e. An aortic angle of <= 60 degrees. 4) A distal iliac landing zone: a. With a length of at least 10 mm; and b. With an inner wall diameter of no less than 8 mm and no greater than 25 mm.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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