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Home » St. Jude’s ‘Intentions’ Result in Warning of Off-Label Claims
St. Jude’s ‘Intentions’ Result in Warning of Off-Label Claims
May 21, 2010
Semantics and intentions appear to be the issue in a warning letter the FDA sent St. Jude Medical, citing it for off-label promotion of its Epicor LP cardiac ablation system and the Epicor UltraCinch LP ablation device.