In Brief: FDA Neurological Devices Panel
This article was originally published in The Gray Sheet
FDA Neurological Devices Panel: Premarket approval application for NeuroControl's Freehand neuroprosthetic device, designed to restore hand grasp in spinal cord injury patients with quadriplegia, is slated for review by the panel Sept. 25, the firm says. The PMA, submitted in October 1995, includes data from 39 patients enrolled in an ongoing study begun in March 1993 ("The Gray Sheet" May 13, I&W-5)...
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