植入式心脏转复除颤器（非CRT）
PMA编号：P980016 · 2026-09-25
广告
决定日期2026-09-25
PMA 编号P980016
产品代码LWS
设备分类第3类
医疗专科U
咨询委员会CV
器械摘要
Implantable cardioverter defibrillator (non-CRT) is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cardiac Rhythm Disease Management. It received FDA 510(k) clearance on 2026-09-25. The device is classified under product code LWS. It was reviewed by the CV advisory panel.
常见问题
What is the Implantable cardioverter defibrillator (non-CRT)?
Implantable cardioverter defibrillator (non-CRT) is a medical device that received FDA 510(k) clearance on 2026-09-25. The listed applicant is Medtronic Cardiac Rhythm Disease Management.
When did Implantable cardioverter defibrillator (non-CRT) receive FDA 510(k) clearance?
The clearance date for Implantable cardioverter defibrillator (non-CRT) can be found in the official FDA records.
Who is the listed applicant for Implantable cardioverter defibrillator (non-CRT)?
The FDA 510(k) record lists Medtronic Cardiac Rhythm Disease Management as the applicant. This does not by itself establish the device manufacturer.
什么是植入式心脏转复除颤器（非CRT）的FDA产品代码？
The FDA product code for Implantable cardioverter defibrillator (non-CRT) is LWS.
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。
广告