Gore Viabahn VBX Balloon Expandable Endoprosthesis

FDA premarket approval P160021 · Iliac covered stent, arterial

PMA numberP160021

Approval

Applicant
W. L. Gore & Associates, Inc.
Received
July 5, 2016
Decision date
January 27, 2017 (APPR)
Supplements
48, latest June 16, 2026
Product code
PRL – Iliac Covered Stent, Arterial

Official FDA PMA record

Approval order statement

Approval for the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is indicated for the treatment of de novo or restenotic lesions found in iliac arteries with reference vessel diameters ranging from 5mm - 13mm and lesion lengths up to 110mm, including lesions at the aortic bifurcation.