Boston Scientific resolves issues of 2006 warning

Wed, 08/11/2010 - 12:45pm
The Associated Press

Boston Scientific Corp. said Wednesday the Food and Drug Administration said issues tied to a 2006 warning letter from the agency about how the medical device maker handled complaints have been resolved.

The letter related to quality management systems the company had in place, and it came after regulators visited Boston Scientific sites that made stents and the Leveen Needle Electrode.

The warning letter also came with a ban on the approval of significant new products that was lifted in 2008.

Boston Scientific shares fell 4.5 percent, or 26 cents, to $5.58 in Wednesday afternoon trading, while the Standard & Poor's 500 index fell nearly 3 percent.


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