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FDA Assembling Advisors To Discuss Pediatric HDE Products

Executive Summary

As part of a periodic review, FDA is bringing together experts to review several products that are conditionally available for pediatric use under the agency's Humanitarian Device Exemption program.

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Pulmonary valved conduit receives FDA Humanitarian Device Exemption approval, firm announces Nov. 24. The bioprosthetic, composed of a bovine jugular vein containing an integral valve that can be used to reconstruct a blood pathway from the right ventricle to the lungs, corrects congenital defects of the right side of the heart in patients under 18. Contegra can be used instead of a human valve, supplies of which are limited, Medtronic notes. The company has been distributing the device outside the U.S. since 1998 and acquired the product from VenPro in 2001...

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