TREO® Abdominal Stent-Graft System

FDA Premarket Approval P190015

Pre-market Approval Supplement Details

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 accessories2. Proximal aortic landing zone with:2a. Infrarenal landing neck length of >= 15mm2b. Aortic neck diameters >= 17 mm and = 15 mm4. Minimum overall aaa treatment length (proximal landing location to distal landing location) of 13 cm5. Minimum overall length from the lowest renal artery to the aortic bifurcation of 9 cm

DeviceTREO® Abdominal Stent-Graft System
Generic NameSystem, Endovascular Graft, Aortic Aneurysm Treatment
ApplicantBolton Medical Inc.
Date Received2019-06-03
Decision Date2020-05-04
PMAP190015
SupplementS
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address Bolton Medical Inc. 799 International Pkwy sunrise, FL 33325
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Approval Order: Approval Order

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Supplement NumberDateSupplement Type
P190015Original Filing

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