Arrow International; Premarket Approval of the Model 3000 Constant Flow Inplantable Pump with Bolus Safety Valve

Özet

The Food and Drug Administration (FDA) is announcing its approval of the application by Arrow International, Walpole, MA, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Model 3000 Constant Flow Implantable Infusion Pump with Bolus Safety Valve. After reviewing the recommendation of the General Hospital and Personal Use Device Section of the General Medical Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of March 11, 1996, of the approval of the application.