Zdrowie i gospodarka · 17.11.1999
Medical Devices; Exemptions From Premarket Notification; Class II Devices
The Food and Drug Administration (FDA) is announcing that it has received a petition requesting an exemption from the premarket notification requirements for vascular tunnelers. FDA is publishing this notice in order to obtain comments on this petition in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).