Medical Device Maker Admits Guilt In FDA Case

Law360, New York (July 31, 2007, 12:00 AM EDT) -- Health care company NuMED Inc. and its chief executive Allen Tower Sr. have been fined almost $2.3 million after pleading guilty in Delaware's federal court to selling medical devices without approval from the U.S. Food and Drug Administration.

The Hopkinton, N.Y.-based company and Tower, which were charged after an investigation by special agents in the FDA's criminal investigation unit, admitted distributing the pediatric heart devices before obtaining premarket approval or clearance from the FDA.

Prosecutors said NuMED manufactured and shipped thousands of unapproved CP stents and...
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