|Trade Name||SMART CONTROL NITINOL STENT SYSTEM|
|Classification Name||stent, iliac|
|Generic Name||iliac stent|
|Supplement Type||real-time process|
|Supplement Reason|| change design/components/specifications - material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for the following change to the deliver system of the s. M. A. R. T. Control nitinol stent system: 1) the wire lumen of the delivery system will be fabricated from different materials. 2) the new wire lumen inner diameter specification has been increased. 3) the proximal land section of the distal tip has been increased. 4) the inner diameter specification of the distal tip has been increase.