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Hospira Submits 510(k) Application to FDA for Symbiq™ Infusion System Modifications
Date:4/4/2011

a is working closely with the FDA to ensure that the Symbiq submission follows all guidelines of the new 510(k) draft guidance for infusion pumps. The timeframe for FDA clearance of the Symbiq upgrade cannot be determined. However, Hospira has dedicated the resources necessary to resume new shipments of the Symbiq infusion system as soon as the 510(k) is cleared.

For more information about the FDA draft guidance for 510(k) infusion pump submissions, visit: Guidance for Industry and FDA Staff - Total Product Life Cycle: Infusion Pump - Premarket Notification [510(k)] Submissions (issued April 23, 2010).

About the Symbiq Infusion System

The Symbiq infusion system is a technologically advanced infusion device with several clinician-friendly features incorporated to help improve workflow and decrease medication errors. With Hospira MedNet™ safety software built into the device, Symbiq was the first general infusion system designed to provide additional medication-error protection by requiring users to select a drug library entry from the safety software for all drug delivery programs. Due to its highly sophisticated technology, Symbiq is one of the first devices to achieve I.V. clinical integration of infusion pumps with electronic health record systems, which can help decrease the number of steps and time required to program the infusion pump.

About Hospira

Hospira, Inc. is a global specialty pharmaceutical and medication delivery company dedicated to Advancing Wellness™. As the world leader in specialty generic injectable pharmaceuticals, Hospira offers one of the broadest portfolios of generic acute-care and oncolo
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SOURCE Hospira, Inc.
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