经皮植入的主动脉瓣,人工瓣膜
PMA编号:P100041 · 2016-03-22
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决定日期2016-03-22
PMA 编号P100041
产品代码NPT
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
Aortic valve, prosthesis, percutaneously delivered is the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2016-03-22. The device is classified under product code NPT. It was reviewed by the CV advisory panel.
常见问题
What is the Aortic valve, prosthesis, percutaneously delivered?
Aortic valve, prosthesis, percutaneously delivered is a medical device that received FDA 510(k) clearance on 2016-03-22. The listed applicant is Edwards Lifesciences, LLC.
When did Aortic valve, prosthesis, percutaneously delivered receive FDA 510(k) clearance?
The clearance date for Aortic valve, prosthesis, percutaneously delivered can be found in the official FDA records.
主动脉瓣,植入式,经皮输送的申请人是谁?
The FDA 510(k) record lists Edwards Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.
主动脉瓣,植入式,经皮输送的FDA产品代码是什么?
FDA产品代码为经皮植入主动脉瓣,人工瓣膜为NPT。
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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