Heart device maker Edwards Lifesciences Corp. said yesterday it received a warning from the FDA about the quality-systems handling at its California facility. The warnings states that Edwards will cease to received FDA premarket approval for devices "reasonably related to those issues." CEO Michael A. Mussallem said the company is fully committed to resolving the issues promptly, and does not expect the matter to have a material impact on its 2007 financial guidance. 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. EW stock was down $1.43 (2.7%) to $50.98 in yesterday's trading.
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