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St. Jude Hopes Its PFO Occluder Gets RESPECT At May FDA Panel

This article was originally published in The Gray Sheet

Executive Summary

St. Jude won a May panel date for its Amplatzer patent foreman ovale occluder PMA, seeking approval to prevent recurrent stroke. It's been a challenging path to this point after the firm's pivotal RESPECT trial did not meet its primary endpoint in 2012.

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