Zdrowie i gospodarka · 09/08/2000

FDA Releases Guidance for Extracorporeal Shock Wave Lithotripters

The Food and Drug Administration (FDA) has made available a guidance document outlining the required information for premarket notifications for extracorporeal shock wave lithotripters intended to treat kidney and ureteral stones, as part of its efforts to reclassify these devices from class III to class II.