FDA Lifts Boston Scientific Warning Letter Restrictions On PMA Approvals
This article was originally published in The Gray Sheet
Executive Summary
Boston Scientific anticipates FDA approval of its Express SD renal stent, among other products, now that the agency has lifted the restrictions on Class III device approvals imposed by a 2006 company-wide warning letter
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Boston Scientific will begin marketing its Express SD renal stent immediately, following receipt of PMA approval Dec. 11
Boston Scientific’s Express SD Renal Stent Gains FDA Approval
Boston Scientific will begin marketing its Express SD renal stent immediately, following receipt of PMA approval Dec. 11
Boston Scientific’s Taxus Liberté approved
Next-generation paclitaxel-eluting coronary stent will launch in the U.S. early next month following FDA approval, the firm announces Oct. 10. The approval was delayed by the firm's 2006 company-wide warning letter, and agency sign-off provides further evidence that the firm has largely resolved related quality issues. Boston Scientific's Taxus Express2 Atom paclitaxel-eluting stent was approved in September (1"The Gray Sheet" Sept. 29, 2008, p. 16). Liberté is indicated for de novo lesions < 28 mm in length in native coronary arteries with diameters of > 2.5 mm to < 4.00 mm. Deemed "approvable" by the agency in March, Liberté is intended to replace Taxus Express and is touted as more "deliverable" by Boston Scientific