FDA Classifies St. Jude Medical Field Action For 447 Of The Company’s Optisure High Voltage Leads As A Class 1 Advisory In The U.S.

"U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx> · Wed, 27 Jan 2016 14:18:17 -0600

Title:     FDA Classifies St. Jude Medical Field Action For 447 Of The Company’s Optisure High Voltage Leads As A Class 1 Advisory In The U.S.

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FDA Classifies St. Jude Medical Field Action For 447 Of The Company’s Optisure High Voltage Leads As A Class 1 Advisory In The U.S.
01/27/2016 02:48 PM EST

St. Jude Medical, Inc. (NYSE:STJ), a global medical device company, today announced that a previously communicated voluntary global field safety action related to the company’s Optisure™ Dual Coil Defibrillation Leads has now been classified as a Class 1 Advisory by the U.S. Food and Drug Administration. The Class 1 Advisory relates to a limited and well-defined group of 447 Optisure leads, 278 of which were distributed in the U.S., which may have been damaged during a manufacturing step.

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