Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
ApplicantBolton 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 TrialsNCT01328197
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S012 
S013 S014 S016 S017 S018 S019 S020 S021 S022 S023 S024 S025 
S026 S027 S029 
-
-