|Trade Name||GORE VIABAHN ENDOPROSTHESIS WITH HEPARIN BIOACTIVE SURFACE|
|Classification Name||system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment|
|Applicant||W.L. GORE & ASSOCIATES,INC|
|Supplement Type||30-day notice|
|Supplement Reason|| process change: manufacturing|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Change in the heat treatment manufacturing procedure, the use of a new container closure system, as well as the addition of two suppliers for a processing aid.