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Advanced Neuromodulation Systems

This article was originally published in The Gray Sheet

Executive Summary

Premarket approval application for the company's totally implanted pulse generator (IPG) spinal cord stimulation for relief of chronic pain of the trunk will be submitted to FDA later this month, ANS announces April 4. Separately, the company will continue to appeal the agency's Feb. 23 denial of its petition to downclassify the SCS IPG from Class III to Class II (1"The Gray Sheet" March 5, 2001, p. 10)

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