Implantable cardioverter defibrillator (non-CRT)
PMA 核准號：P980023 · 2026-09-25
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器材摘要
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.
常見問題
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.
植入式心臟去極化器（非CRT）的FDA產品代碼是什麼？
The FDA product code for Implantable cardioverter defibrillator (non-CRT) is LWS.
相關臨床試驗
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官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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