脉冲发生器，起搏器，植入式，具有心脏再同步（CRT-P）
PMA编号：P030035 · 2026-07-21
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决定日期2026-07-21
PMA 编号P030035
产品代码NKE
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
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code NKE. It was reviewed by the CV advisory panel.
常见问题
What is the Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is ABBOTT MEDICAL.
When did Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) receive FDA 510(k) clearance?
The clearance date for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) can be found in the official FDA records.
脉冲发生器、心脏起搏器、植入式、具有心脏再同步（CRT-P）功能的设备，列出的申请人是谁？
The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.
FDA脉冲发生器、心脏起搏器、植入式、具有心脏再同步（CRT-P）的产品代码是什么？
FDA产品代码为脉冲发生器、起搏器、植入式，具有心脏再同步（CRT-P）功能的为NKE。
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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