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FDA Orders St. Jude To Expand Surveillance Of ICD Leads, Including Durata

The agency announced Section 522 post-market surveillance orders that target St. Jude Medical’s recalled Riata leads, as well as the currently marketed Durata leads.

FDA is requiring St. Jude Medical Inc. to augment its post-market surveillance efforts for its implantable cardioverter defibrillator leads, including its currently marketed Durata lead, based on concerns about insulation failure.

The agency announced Section 522 post-market surveillance orders Aug. 16, requiring three-year studies of the firm’s Riata and Riata ST ICD leads, which were removed from the market in 2010...

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