clearance from the FDA for its Enteral Expres new Enteral
Nutrition Pump, to be marketed worldwide by Tyco Healthcare.
(September 6th 2001)
Debiotech announced today that it has received
510(k) clearance for its Enteral Exprés pump and giving sets
from the US Food and Drug Administration (FDA). "We are very
pleased with this clearance, as it will enable the marketing of
the Enteral Exprés product line in the United States",
says Ary Saaman, Director of Regulatory Affairs for Debiotech.
Debiotech already obtained clearance in the US
from the Food and Drug Administration (FDA) for its IV Expres infusion
The Enteral Exprés is Debiotech's micropump
for Enteral Nutrition. It combines ease of use with a variety of
infusion modes and advanced features, e.g. remote communication.
Earlier this year, Debiotech licensed the pump worldwide to Tyco