It received a warning letter in January 2006 regarding its drug-coated stents. The Boston Globe reports that it doesn't expect that letter to be resolved until the second half of 2007.
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FDA Lifts Warning Letter on Guidant
After reinspecting Guidant's cardiac rhythm management site in St. Paul, FDA has lifted a warning letter on the company. Now a division of Boston Scientific, Guidant received the warning in December 2005 when FDA inspectors found quality control problems at the site. The letter also came following a series of defibrillator recalls by the company. Boston Scientific's quality system improvements paid off, as FDA's reinspection of the facility last year reported no problems. The company is still not in the clear though.
