Friday, November 12, 2010

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Gastroenterology and Urology Devices Panel of the Medical Devices Advisory Committee

Meeting on December 2 from 8 a.m. to 6 p.m. (Day 1 of 2)

Agenda: On December 2, 2010, the committee will discuss, make recommendations, and vote on information related to the premarket approval application (PMA) for SOLESTA, sponsored by Oceana Therapeutics, Inc. SOLESTA is indicated for the treatment of fecal incontinence in patients who have failed conservative therapy.

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