除颤器，自动植入式心脏起搏器，具有心脏再同步（CRT-D）
PMA编号：P880006 · 2016-02-12
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决定日期2016-02-12
PMA 编号P880006
产品代码NIK
设备分类第3类
医疗专科U
咨询委员会CV
请注意，由于原文未提供具体内容，以下是一个示例翻译：
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产品名称：[产品名称]
公司名称：[公司名称]
FDA批准号：[FDA批准号]
510(k)申请号：[510(k)申请号]
PMA申请号：[PMA申请号]
临床试验注册号：[NCT]
PubMed ID：[PMID]
产品标识符：[标识符]
产品URL：[URL]
---
请将上述示例中的[产品名称]、[公司名称]、[FDA批准号]等占位符替换为实际内容。
器械摘要
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-02-12. The device is classified under product code NIK. It was reviewed by the CV advisory panel.
常见问题
What is the Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)?
Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is St. Jude Medical, Inc..
When did Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) receive FDA 510(k) clearance?
The clearance date for Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) can be found in the official FDA records.
谁是自动植入式心脏复律除颤器（CRT-D）的列名申请人？
The FDA 510(k) record lists St. Jude Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.
什么是自动植入式心脏除颤器（CRT-D）的FDA产品代码？
FDA产品代码为自动植入式心脏除颤器（带心脏再同步治疗，CRT-D）的Defibrillator是NIK。
相关临床试验
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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