美敦力公司；Interstim骶神经刺激（SNS）系统的上市前批准——美国食品药品监督管理局。通知。
Medtronic, Inc.; premarket approval of the Interstim Sacral Nerve Stimulation (SNS) System--FDA. Notice.
出版信息
Fed Regist. 1998 Jan 29;63(19):4457.
PMID:10177327
Abstract
The Food and Drug Administration (FDA) is announcing its approval of the application by Medtronic, Inc., Minneapolis, MN, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the Interstim Sacral Nerve Stimulation (SNS) System. After reviewing the recommendation of the Gastroenterology and Urology Devices Panel, FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 29, 1997, of the approval of the application.
摘要
美国食品药品监督管理局（FDA）宣布批准明尼苏达州明尼阿波利斯市美敦力公司（Medtronic, Inc.）依据《联邦食品、药品和化妆品法案》（该法案）提交的骶神经刺激（SNS）系统上市前批准申请。在审查了胃肠病学和泌尿外科器械专家小组的建议后，FDA的器械与放射健康中心（CDRH）于1997年9月29日致函申请人，通知其申请已获批准。
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