U.S. Department of Justice
Colorado-Based Spectranetics Corporation to Pay $5 Million to Resolve Allegations Relating to its Medical Devices
Published in Medical Devices and Surgical Technology Week, January 17th, 2010
Spectranetics Corporation, a medical device manufacturer, has agreed to pay the United States $4.9 million in civil damages plus a $100,000 forfeiture to resolve claims against the company, the Justice Department announced. The claims arise from allegations that the company illegally imported unapproved medical devices and provided them to physicians for use in patients, conducted a clinical study in a manner that failed to comply with federal regulations and promoted certain products for procedures for which the company had not received Food and Drug Administration approval or clearance.
The company manufactures, distributes and sells certain medical lasers and...
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