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Extracorporeal shock wave lithotripters

This article was originally published in The Gray Sheet

Executive Summary

FDA proposed rule published Feb. 8 would reclassify the devices from Class III to Class II when intended to fragment kidney and ureteral calculi. A draft guidance released by the agency the same day would serve as a special control for the devices. According to the document, 510(k)s for lithotripters with mechanisms of action and shock wave characteristics similar to existing devices would require data from 20 patients at two sites. The stipulation is in line with a recommendation made by FDA's Gastroenterology and Urology Devices Panel in July ("The Gray Sheet" Aug. 3, 1998, p. 8)
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