FDA Warns Edwards Over Quality Handling Issues


February 23, 2007

Feb. 23, 2007 — Heart device maker Edwards Lifesciences Corp. received a warning this week from the FDA about the quality-systems handling at its California facility, the Wall Street Journal reported. In the warning FDA told Edwards the company will not be receiving FDA premarket approval for devices "reasonably related to those issues."

According to Edwards CEO Michael A. Mussallem, the company is fully committed to quickly resolving the issues and does not anticipate the matter to have a material impact on its 2007 financial strength and direction.

Products on its horizon that require FDA approval include a new use for its LifeStent and a next-gen replacement valve for the heart's mitral position.

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