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Zdrowie i gospodarka · 30.04.2001

Neurological Devices; Reclassification of the Totally Implanted Spinal Cord Stimulator; Denial of Petition

The Food and Drug Administration (FDA) is announcing that it has denied a petition submitted by Advanced Neuromodulation Systems, Inc. (ANS), to reclassify the totally implanted spinal cord stimulator (SCS) for treatment of chronic intractable pain of the trunk or limbs from class III into class II. FDA had previously made available for public comment the recommendation of the Neurological Devices Panel (the Panel) on the reclassification petition and FDA's tentative findings on the Panel's recommendation. After considering all the available information, including the public comments on the Panel's recommendation, FDA denied the reclassification petition by order in a letter to the petitioner.

Source: Federal Register — Food and Drug AdministrationOpen original release →