In 2006 the FDA issued the company a rare "corporate warning letter," which barred the approval of significant new products. Boston Scientific Chief Executive Jim Tobin said the agency has lifted the ban on product approvals. The formal letter remains in place due to issues surrounding the company's reporting of complaints and malfunctions of its devices.
Tobin told analysts on an earnings call that the company was actively working to resolve those issues.
Many analysts had previously suggested the company was making progress toward resolving FDA's complaints. Earlier this month FDA approved the company's next-generation Taxus Liberte stent, which was launched in Europe in 2005 but had been delayed by the warning letter.