SMART FLEX 6x150 BIL, 120cm The S.M.A.R.T.¿ Flex Biliary Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.

Reason: There is a potential for distal tip dislodgement or separation.

Code information: Product Code: SF06150MB; Lot No. 266415, 266417, and 266419

Distribution pattern: US Distribution to states of: CA, FL, IN, LA, OH, OK, TX and OUS distribution to country of Canada.