Physio-Control makes progress with FDA
2008-05-01
Puget Sound Business Journal (Seattle)
Defibrillator company Physio-Control Inc. said it's reached a deal with the Food and Drug Administration regarding quality improvements on external defibrillators.
In January 2007, Physio-Control in Redmond halted shipments of its external defibrillators to focus on "quality system issues." Two months later, it laid off a reported 25 percent of its work force.
On Friday, the company said it filed an agreement with the FDA regarding improvements on its external defibrillators, which must be approved by the U.S. District Court for the Western District of Washington in Seattle.
"During the last year, we've made significant investments and improvements to our quality systems and we are pleased to have a plan that formalizes the path to resume full distribution," said Brian Webster, president of Physio-Control, a unit of Medtronic Inc. (NYSE: MDT) of Minnesota, in a statement.
Source: Puget Sound Business Journal (Seattle). Monday, April 28, 2009 - 9:39 AM PDT
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