Hospira Inc. (HSP) Monday said it submitted a 510(k) application with the U.S. Food and Drug Administration 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 The submission is one of the first developed to align with the recent FDA draft guidance for 510(k) infusion pump clearances.
"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." said Sumant Ramachandra, senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira.
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. Hospira submitted the 510(k) application to the FDA on March 31, 2011.
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