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Approval to modify the name and package label for the lifestentvascular stent systems. specifically, the word "flexstar" will be removed from the trade nameand "& biliary" will be added to the device package labels to reflect the cleared biliary indication for this device. the device, as modified, will be marketed under the trade name lifestentvascular stent system and lifestent xl vascular stent system and is indicated forimprovement of luminal diameter in the treatment of de-novo or restenotic lesion in the nativesfa and proximal popliteal arteries.
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