Implantable cardioverter defibrillator (non-CRT)
PMA 核准號：P980016 · 2026-09-25
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決定日期2026-09-25
PMA 編號P980016
產品代碼LWS
器械分類3 類
醫療專科U
諮詢委員會CV
器材摘要
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 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.
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
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
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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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