FDA clears St. Jude's Calif. plant

July 2, 2014 5:56 PM

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The government expressed satisfaction with improvements at a factory where St. Jude Medical Inc. makes defibrillator parts, the company said Wednesday, clearing an issue that threatened approval of new products.

The U.S. Food and Drug Administration in January last year sent a warning letter to the company about processes at St. Jude’s plant in Sylmar, Calif., where it made leads for its primary defibrillator, called Durata. A lead is a wire that connects the defibrillator to a heart.

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