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Correction on Medtronic’s InterStim neurostimulator

This article was originally published in The Gray Sheet

Executive Summary

The sacral nerve neurostimulation implant, for which Medtronic recently submitted a PMA application for treatment of fecal incontinence, was originally approved in 1997 for urinary incontinence. "The Gray Sheet" had erroneously reported that the urinary indication was first approved in 2006 (1"The Gray Sheet" Oct. 27, 2008, In Brief)

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Medtronic InterStim

Firm submits a PMA application for treatment of fecal incontinence with the neurostimulation implant, anticipating a U.S. launch in 2009, Medtronic announces Oct. 22. The device, which works by stimulating the sacral nerve, has been approved since 2006 for urinary incontinence (1"The Gray Sheet" July 10, 2006, In Brief)

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