|Trade Name||GORE VIABAHN ENDOPROSTHESIS|
|Classification Name||stent, superficial femoral artery|
|Applicant||W.L. GORE & ASSOCIATES,INC|
|Supplement Type||135 review track for 30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for: 1) a change in the type of cooling gas; 2) a change in the application of the coolant; and 3) the addition of a temperature controller.