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CDRH Shocks ANS, Denies Downclassification of Spinal Cord Stimulator

This article was originally published in The Gray Sheet

Executive Summary

FDA inspections of design controls under the Quality Systems Regulation do not provide enough assurance against device failure to allow the downclassification of the Class III totally implanted spinal cord stimulator (SCS) for pain relief, the agency maintains in a Feb. 23 letter to Advanced Neuromodulation Systems.

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ANS PMA For Genesis SCS System Relies on Clinical Literature Studies

Advanced Neuromodulation Systems supported the efficacy of its recently approved Genesis implantable spinal cord stimulator (SCS) using three clinical studies performed with Medtronic's SCS system

ANS PMA For Genesis SCS System Relies on Clinical Literature Studies

Advanced Neuromodulation Systems supported the efficacy of its recently approved Genesis implantable spinal cord stimulator (SCS) using three clinical studies performed with Medtronic's SCS system

ANS

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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