FDA chief OKs new review of Ethicon sedation system

03/21/2011 | MassDevice.com (Boston)

FDA Commissioner Margaret Hamburg has asked an advisory panel to conduct another review of Ethicon Endo-Surgery's premarket approval application for the Sedasys computer-aided sedation system, intended for use in gastroenterological procedures. The Johnson & Johnson unit has been asking for reconsideration of the device since March of last year.

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