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Downclassification Of Implantable Spinal Cord Stimulators Recommended

This article was originally published in The Gray Sheet

Executive Summary

The issue of battery life in the Implantable Pulse Generator (IPG) spinal cord stimulator could best be addressed in labeling, FDA's Neurological Devices Panel agreed Sept. 17 in a 5-1 vote recommending downclassification of the product from Class III to Class II for the indication of pain relief.

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