Spectranetics Settles FDA Probe
December 30, 2009 (FinancialWire) — Spectranetics Corp. (NASDAQ: SPNC) said it has settled matters related to the federal investigation initiated by the Food & Drug Administration and U.S. Immigration and Customs Enforcement, which was previously reported in a press release dated September 4, 2008.
The resolution includes a non-prosecution agreement and a civil settlement agreement with the United States Department of Justice, as well as a Corporate Integrity Agreement with the Office of the Inspector General for the United States Department of Health and Human Services.
Significant terms of the agreements, subject to certain conditions outlined therein, include an agreement not to prosecute the company, a $4.9 million payment in consideration of a release from certain civil or administrative monetary claims resulting from certain alleged conduct associated with the federal investigation, and a separate agreement that specifies certain corporate integrity obligations.
In addition, Spectranetics has agreed to a forfeiture of $100,000 in cash or property to be executed in the near future. There are no criminal charges against the company.
Spectranetics manufactures and markets an Excimer Laser System approved in the United States, Canada, Europe and Japan for use in minimally invasive interventional procedures within the cardiovascular system.
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