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St. Jude Neuromodulation draws warning letter

This article was originally published in The Gray Sheet

Executive Summary

FDA warning letter dated July 1 cites non-conformities with current good manufacturing practices at St. Jude's Neuromodulation division facilities in Plano, Tex., and Hackettstown, N.J., which were observed during FDA inspections in March and April. St. Jude says it has already begun addressing the issues, which pertain to manufacturing process and documentation issues, and not specific device deficiencies, according to the company. FDA says it will not approve any St. Jude Neuromodulation PMA application until the warning letter is resolved. But St. Jude notes that it does not have any major neuromodulation device filings pending. The company recently completed enrollment of a pivotal study of its Libra and LibraXP deep brain stimulation systems for symptomatic Parkinson's disease. The company says it expects to file a PMA for the indication in about 18 months

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