www.fdanews.com/articles/122380-company-gets-510-k-ce-marking-for-esophageal-stent
Company Gets 510(k), CE Marking for Esophageal Stent
November 20, 2009
Boston Scientific received 510(k) clearance and
CE Marking for its WallFlex fully covered esophageal stent to treat malignant esophageal obstructions, according to a company statement. These obstructions
may make it difficult for patients to swallow. The company’s partially covered esophageal stent
was cleared for marketing in Europe and the U.S. last year.