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This article was originally published in The Gray Sheet
Company submits final module of its PMA application for the totally implantable pulse generator (IPG) spinal cord stimulator for relief of chronic pain of the trunk and/or limbs. Advanced Neuromodulation Systems also continues to pursue its appeal regarding FDA's Feb. 23 denial of its reclassification petition for the IPG from a Class III to a Class II device. (1"The Gray Sheet" March 5, 2001, p. 10)
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