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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTREO® Abdominal Stent-Graft System
Generic Namesystem, endovascular graft, aortic aneurysm treatment
Applicant
Bolton Medical Inc.
799 international pkwy
sunrise, FL 33325
PMA NumberP190015
Date Received06/03/2019
Decision Date05/04/2020
Product Code MIH 
Docket Number 20M-1311
Notice Date 05/07/2020
Advisory Committee Cardiovascular
Clinical Trials NCT01328197
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for TREO® Abdominal Stent-Graft System. This device is indicated for use in the endovascular treatment of patients with infrarenal abdominal aortic and aorto-iliac aneurysms with the following characteristics:1. Adequate iliac or femoral access compatible with the required delivery systems and accessories;2. Proximal aortic landing zone with: 2a. Infrarenal landing neck length of >= 15mm; 2b. Aortic neck diameters >= 17 mm and <= 32 mm; 2c. Suprarenal neck angle of <= 45 degrees; 2d. Infrarenal neck angle of <= 60 degrees. 3. Distal iliac landing zone with: 3a. an inside diameter of 8 mm – 13 mm and a length of >= 10 mm; or 3b. an inside diameter of > 13 mm – 20 mm and a length of >= 15 mm.4. Minimum overall AAA treatment length (proximal landing location to distal landing location) of 13 cm; and5. Minimum overall length from the lowest renal artery to the aortic bifurcation of 9 cm.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 
S009 
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