植入式心脏转复除颤器（非CRT）
PMA编号：P980023 · 2026-09-25
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器械摘要
Implantable cardioverter defibrillator (non-CRT) is the device name listed in this FDA 510(k) record. The listed applicant is Biotronik, Inc.. 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 Biotronik, Inc..
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 Biotronik, Inc. 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.
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官方来源
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