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Guideline for the Arrangement and Content of a Premarket Approval (PMA)Application for a Cochlear Implant in Adults at Least 18 Years of Age

机译：18岁以下成人人工耳蜗植入前上市批准（pma）申请的安排和内容指南

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;Contents: Cover Page; Table of Contents; Summary of Safety and Effectiveness;Device Characteristics and Manufacturing; Performance Standards; Technical Sections; One Investigator; Reports and Other Information; Samples; Labeling; Environmental Assessment; Other Information; Appendix.

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年度 1990
页码 1-26
总页数 26
原文格式 PDF
正文语种 eng
中图分类工业技术;
关键词
Medical devices; Cochlear implants; Applications; Adults; Guideline; Arrangement; Content; Safety; Effectiveness; Performance standards;

机译：医疗器械;人工耳蜗;应用;成人;指南;安排;内容;安全;有效性;性能标准;

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专利

1. Simultaneous bilateral cochlear implantation in children aged 12-18 months is safe and can be performed using standard cochlear implant surgical techniques [J] . Gao Zhiqiang, Wang Suju, Yang Hua, European archives of oto-rhino-laryngology: Official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) . 2020,第8期

机译：12-18个月儿童的同时双侧耳蜗植入是安全的，可以使用标准耳蜗植入手术技术进行
2. FDA Approval of cardiac implantable electronic devices via original and supplement premarket approval pathways, 1979-2012 [J] . RomeB.N., KramerD.B., KesselheimA.S. JAMA: the Journal of the American Medical Association . 2014,第4期

机译：1979-2012年，FDA通过原始和补充上市前批准途径批准了心脏植入式电子设备
3. Nijmegen Cochlear Implant Questionnaire (NCIQ): translation, cultural adaptation, and application in adults with cochlear implants [J] . CoDAS . 2017,第1期

机译：奈梅亨人工耳蜗调查问卷（NCIQ）：翻译，文化适应以及在成人人工耳蜗中的应用
4. Loaded Gait Phase of Normalised Comparison between Older Adults Aged 65-80 Years and Adults Aged 25-45 Years [C] . Nibras S. Abbas, Albert K. Chong IEEE Symposium on Computer Applications Industrial Electronics . 2021

机译：65-80岁及25-45岁年龄较大的成人的老年人的正常比较的加载步态阶段
5. Recognition and localization of speech by adult cochlear implant recipients wearing a digital hearing aid in the non-implanted ear (bimodal hearing) [D] . Potts, Lisa G. 2006

机译：成年人工耳蜗植入者在非植入式耳朵中佩戴数字助听器的语音识别和定位（双峰听力）
6. FDA Approval of Cardiac Implantable Electronic Devices via Original and Supplement Premarket Approval Pathways 1979-2012 [O] . Benjamin N. Rome, Daniel B. Kramer, Aaron S. Kesselheim -1

机译：FDA通过原始和补充上市前批准途径对心脏植入式电子设备的批准1979-2012年
7. Knowledge translation of the Canadian 24-Hour Movement Guidelines for Adults aged 18–64 years and Adults aged 65 years or older: a collaborative movement guideline knowledge translation process [O] . Jennifer R. Tomasone, Stephanie M. Flood, Amy E. Latimer-Cheung, 2020

机译：加拿大24小时运动指南的知识翻译成年人18-64岁及65岁或以上成年人的成年人：协作运动指南知识翻译过程
8. Premarket Approval (PMA) Manual [R] . Kyper, C. 1993

机译：上市前批准（pma）手册

Guideline for the Arrangement and Content of a Premarket Approval (PMA)Application for a Cochlear Implant in Adults at Least 18 Years of Age

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