Abbott Secures FDA and CE Mark Approvals for Amplatzer Delivery System

Abbott's Amplatzer Piccolo™ Delivery System Receives FDA Clearance and CE Mark to Optimize Procedures for Premature Babies With a Hole in the Heart

First and only delivery system designed specifically for premature infants with a patent ductus arteriosus (PDA), a life-threatening opening in their heartNew delivery system enables precise placement of Abbott's Amplatzer Piccolo Occluder in the tiniest babiesA PDA requiring treatment is…

Abbott secures FDA and CE Mark approvals for Amplatzer delivery system

Abbott has secured the US Food and Drug Administration (FDA) and CE Mark approval for its Amplatzer Piccolo Delivery System, designed for premature infants diagnosed with patent ductus arteriosus (PDA).The post Abbott secures FDA and CE Mark approvals for Amplatzer delivery system appeared first on Medical Device Network.

Delivery system for PDA closure in premature infants gains regulatory approvals

Abbott has received US Food and Drug Administration (FDA) clearance and CE mark for its Amplatzer Piccolo delivery system, which is used with the company’s Amplatzer Piccolo occluder. The new delivery system is designed specifically to treat premature babies (some weighing as little as two pounds) with a hole in the heart known as a patent ductus arteriosus (PDA). “Abbott’s new Amplatzer Piccolo delivery system is a transformative step forward i…