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Physio-Control signs consent decree with FDA on QA issues:

This article was originally published in Clinica

Executive Summary

Physio-Control, a Medtronic subsidiary and developer of external defibrillators, has agreed with the US FDA on a plan that would resolve quality issues at its Redmond, Washington facility and enable the company to resume US distribution of its products. Medtronic suspended US shipments of the defibrillators from the plant in January 2007 (see Clinica No 1241, p 13). According to Brian Webster, president of Physio-Control, the Minneapolis, Minnesota-based firm has made "significant investments and improvements" to its technology over the last year. Meanwhile, shipments of the products to non-US customers will continue as normal.

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