冠状动脉药物洗脱支架
PMA编号：P170008 · 2026-08-06
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决定日期2026-08-06
PMA 编号P170008
产品代码NIQ
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：
---
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
Coronary drug-eluting stent is the device name listed in this FDA 510(k) record. The listed applicant is Medinol, Ltd.. It received FDA 510(k) clearance on 2026-08-06. The device is classified under product code NIQ. It was reviewed by the CV advisory panel.
常见问题
What is the Coronary drug-eluting stent?
Coronary drug-eluting stent is a medical device that received FDA 510(k) clearance on 2026-08-06. The listed applicant is Medinol, Ltd..
When did Coronary drug-eluting stent receive FDA 510(k) clearance?
The clearance date for Coronary drug-eluting stent can be found in the official FDA records.
Coronary 药物洗脱支架的申请人是谁？
The FDA 510(k) record lists Medinol, Ltd. as the applicant. This does not by itself establish the device manufacturer.
FDA产品代码是多少，用于冠状动脉药物洗脱支架？
FDA产品代码为Coronary drug-eluting stent的是NIQ。
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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