February 16, 2006
FDA Places New Restrictions on Guidant
Posted at February 16, 2006 9:10 AM in Defective Medical Devices
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New limits imposed by the FDA on Guidant, maker of an implantable heart defibrillator found to be defective, will make it difficult for new products made by the company to be approved for commercial sale, as the agency applies pressure to the company to improve its manufacturing procedures.
In the letter, sent a week ago, the agency said Guidant had not fully responded to its concerns about manufacturing procedures at the company's biggest plant.
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