Medical Devices; Exemptions From Premarket Notification; Class II Devices; Vascular Tunnelers
Information
Type
Rule
Regulated products
Medical Devices
Published
March 3, 2000
Last updated
March 3, 2000
Description
Document number 00-5159. The Food and Drug Administration (FDA) is publishing an order granting in part a petition requesting exemption from the premarket notification requirements for vascular tunnelers with certain limitations. This rule will exempt from premarket notification stainless steel vascular tunnelers of single unit construction. FDA is publishing this order in accordance with procedures established by the Food and Drug Administration Modernization Act of 1997 (FDAMA).
Tags
Organization
Country / Region
United States
License
Other (Public Domain)