A U.S. District Court Judge in New Hampshire has entered into a consent decree to stop Maquet Holding B.V. & Co KG from making and distributing some hernia mesh, vascular graft and vascular patch products at its Atrium Medical Corp. facility in Hudson, N.H., after FDA issued warning letters to correct quality system and other device manufacturing regulations.
展开▼
机译:美国新罕布什尔州地方法院法官已达成一项同意令,以阻止Maquet Holding BV&Co KG在获得FDA批准后,在其位于新罕布什尔州哈德逊的Atrium Medical Corp.工厂中制造和分发一些疝气网,血管移植物和血管贴剂产品。发出警告信以更正质量体系和其他设备制造法规。
展开▼