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In Brief: Medtronic

This article was originally published in The Gray Sheet

Executive Summary

Medtronic: Receives clearance on Dec. 23 for its model 550M Bio-Console pump speed controller used with the company's Bio-pump." The 550M is designed to allow use on a Sarns 9000 perfusion system, facilitating "easy placement and use of the controller with Sarns roller pumps and their controllers" in the operating room. In September, Medtronic received an FDA warning letter for distributing the product without premarket clearance ("The Gray Sheet" Oct. 10, 1994, p. 19)...



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