Hospira has submitted a 510(k) application with the US Food and Drug Administration (FDA) for modifications to the Symbiq infusion system, a technologically advanced infusion device.
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 R&D and Medical & Regulatory Affairs senior vice president and chief scientific officer Sumant Ramachandra said with this submission complete, they are on track to meet commitments for resuming new customer shipments of Symbiq infusion pumps and advancing the continuous evolution of the infusion pump.
"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," Ramachandra said.