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• Saturday, March 27th, 2010

Boston Scientific Inc.’s shares fell after the Food and Drug Administration said it has not completed a review of paperwork the Natick company filed after recalling its cardiac defibrillator devices.

The FDA expects to complete its review within 30 days, a spokeswoman said.

Boston Scientific announced March 15 that it had stopped sales of implantable cardiac defibrillators and was voluntarily recalling the devices because two manufacturing changes had not been submitted for review to the FDA, as required. The FDA says doctors should not use the defibrillators until the changes are approved.

A Boston Scientific spokesman had no comment.

http://www.boston.com/business/healthcare/articles/2010/03/26/fda_reviewing_boston_scientific_data/

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