Tag: FDA

  • FDA Contegra Pulmonary Valved Conduit H020003 Instructions

    FDA Contegra Pulmonary Valved Conduit H020003 Instructions

    Contegra® Pulmonary Valved ConduitH020003 Presentation to the Pediatric Advisory Committee September 12, 2017 Dora Vega, MD, PhDDivision of EpidemiologyOffice of Surveillance and BiometricsCenter for Devices & Radiological Health Device Description A glutaraldehyde-crosslinked, heterologous bovine jugular vein with a competent tri-leaflet venous valve Indica)ons for Use Correc)on or reconstruc)on of the right ventricular outflow tract (RVOT)…