|Trade Name||GORE VIABAHN ENDOPROSTHESIS|
|Classification Name||stent, superficial femoral artery|
|Applicant||W.L. GORE & ASSOCIATES,INC|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Alternate fep film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.