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Medtronic's MIS

This article was originally published in The Gray Sheet

Executive Summary

Indictment against Micro Interventional Systems founders Ronald Dieck and Erin McGurk is dropped by Northern California federal prosecutors Feb. 27. Dieck and McGurk were charged with defrauding the FDA by falsifying data in 510(k) submissions before and after the firm's acquisition by Medtronic in November 1995. Medtronic divested MIS in 1997 and filed a civil action in 1998. A stay on Medtronic's civil case against Dieck and McGurk is expected to be lifted and the suit will proceed in arbitration

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Former Director of Regulatory and Clinical Affairs and Quality Assurance, Anna Carillo, is sentenced to 10 months in prison by a Northern California federal court for submitting fraudulent 510(k)s to FDA. Carillo pleaded guilty to the charges in April. Similar charges against the now-defunct firm's founders were dropped in February. MIS was acquired by Medtronic in November 1995 and subsequently divested in 1997 following discovery of the falsified submissions (1"The Gray Sheet" March 5, 2001, In Brief)

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