|Trade Name||GORE VIABAHN ENDOPROSTHESIS|
|Classification Name||stent, superficial femoral artery|
|Applicant||W.L. GORE & ASSOCIATES,INC|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications - component|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval to modify the design platform of the large diameter device (9-13mm diameter) so that it is identical to the currently approved smaller diameter devices. The design platform modification includes changes to the delivery system and associated manufacturing changes.