Regulation of Medical Devices in the United States and European Union

被引：170

作者：

Kramer, Daniel B. ^{[1
,2
]}

Xu, Shuai ^{[1
]}

Kesselheim, Aaron S. ^{[1
,3
]}

机构：

[1] Harvard Univ, Sch Med, Boston, MA 02114 USA

[2] Beth Israel Deaconess Med Ctr, Div Cardiovasc, Boston, MA 02215 USA

[3] Brigham & Womens Hosp, Dept Med, Div Pharmacoepidemiol & Pharmacoecon, Boston, MA 02115 USA

来源：

NEW ENGLAND JOURNAL OF MEDICINE | 2012年 / 366卷 / 09期

关键词：

LEFT-ATRIAL-APPENDAGE; CARDIOVASCULAR DEVICES; CLINICAL-EVALUATION; APPROVAL PROCESS; AORTIC-STENOSIS; PUBLIC-HEALTH; FDA; CLOSURE; TRIAL; INTERVENTION;

D O I：

10.1056/NEJMhle1113918

中图分类号：

R5 [内科学];

学科分类号：

1002 ; 100201 ;

摘要：

引用

页码：848 / 855

页数：8

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