Uromedica appeals to device center's chief over incontinence device

04/7/2010 | MedCityNews.com

Uromedica appealed to Dr. Jeffrey Shuren, who heads the FDA's Center for Devices and Radiological Health, to review the agency's decision not to approve its premarket-approval application for a balloon device used for treating urinary incontinence. Mark DuVal, a lawyer who represents Uromedica, said he hopes Shuren will send the company's case to an advisory committee.

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