Hospira seeks FDA 510(k) clearance for Symbiq infusion system modifications

Hospira, Inc. (NYSE: HSP), a leading provider of clinical information and medication delivery technologies, today announced that the company has submitted a 510(k) application with the U.S. Food and Drug Administration (FDA) for modifications to the Symbiq™ infusion system. The submission is one of the first developed to align with the recent FDA draft guidance for 510(k) infusion pump clearances.

"With this submission complete, we are on track to meet our commitments for resuming new customer shipments of Symbiq infusion pumps and advancing the continuous evolution of one of the most innovative infusion platforms in the hospital today," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "As one of the first companies to file an application under the draft FDA guidance for infusion pumps, we are looking forward to continuing to work with the Agency through this new and innovative regulatory process."

The 510(k) submission to FDA for clearance of the Symbiq infusion system version 3.11 identifies modifications Hospira has made to further enhance the reliability of the infusion pump.  In 2010, Hospira voluntarily placed shipments of the Symbiq pump on hold for customers, while the company finalized the proposed product upgrades. Hospira regularly communicates with current Symbiq customers regarding the status of the system modifications, and plans to upgrade all of the Symbiq infusion pumps currently in use once the FDA provides clearance.  Hospira submitted the 510(k) application to the FDA on March 31, 2011.

Hospira is working closely with the FDA to ensure that the Symbiq submission follows all guidelines of the new 510(k) draft guidance for infusion pumps.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.

Source:

Hospira, Inc.

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