可植入式脈搏發生器，起搏器（非CRT）
PMA 核准號：P820003 · 2025-03-20
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決定日期2025-03-20
PMA 編號P820003
產品代碼LWP
器械分類3 類
醫療專科U
諮詢委員會履歷
器材摘要
Implantable pulse generator, pacemaker (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 2025-03-20. The device is classified under product code LWP. It was reviewed by the CV advisory panel.
常見問題
What is the Implantable pulse generator, pacemaker (non-CRT)?
Implantable pulse generator, pacemaker (non-CRT) is a medical device that received FDA 510(k) clearance on 2025-03-20. The listed applicant is Medtronic Cardiac Rhythm Disease Management.
When did Implantable pulse generator, pacemaker (non-CRT) receive FDA 510(k) clearance?
The clearance date for Implantable pulse generator, pacemaker (non-CRT) can be found in the official FDA records.
誰是植入式脈衝發生器、起搏器（非CRT）的登記申請人？
The FDA 510(k) record lists Medtronic Cardiac Rhythm Disease Management as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為植入式脈搏發生器，起搏器（非CRT）是什麼？
FDA產品代碼對於植入式脈搏發生器、起搏器（非CRT）為LWP。
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。
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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