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MIS Execs Allegedly Defrauded FDA During Acquisition Talks With Medtronic

This article was originally published in The Gray Sheet

Executive Summary

While Micro Interventional Systems was in discussions with Medtronic about a possible acquisition in November 1995, two executives at the Sunnyvale, California-based firm allegedly were falsifying data in various 510(k) submissions to FDA in an apparent attempt to impress Medtronic with the breadth of MIS' neurovascular product pipeline.
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