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.
About The FDA
The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
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