心脏瓣膜，非同种异体组织
PMA编号：P040021 · 2026-09-18
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决定日期2026-09-18
PMA 编号P040021
产品代码LWR
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
heart-valve, non-allograft tissue is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-09-18. The device is classified under product code LWR. It was reviewed by the CV advisory panel.
常见问题
What is the heart-valve, non-allograft tissue?
heart-valve, non-allograft tissue is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is ABBOTT MEDICAL.
When did heart-valve, non-allograft tissue receive FDA 510(k) clearance?
The clearance date for heart-valve, non-allograft tissue can be found in the official FDA records.
心脏瓣膜、非同种异体组织产品的申请人是谁？
The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.
心脏瓣膜非同种异体组织的FDA产品代码是什么？
FDA心脏瓣膜非同种异体组织的产品代码是LWR。
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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