心臟節律發生器，起搏器，可植入式，具有心臟同步化（CRT-P）功能
PMA 核准號：P030035 · 2026-07-21
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器材摘要
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code NKE. It was reviewed by the CV advisory panel.
常見問題
What is the Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P)?
Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is ABBOTT MEDICAL.
When did Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) receive FDA 510(k) clearance?
The clearance date for Pulse generator, pacemaker, implantable, with cardiac resynchronization (CRT-P) can be found in the official FDA records.
誰是列出的 Pulse generator, pacemaker, 埋入式，具有心臟節律重整（CRT-P）的申請人？
The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為何？對於心臟起搏器、植入式、具有心臟節律重整（CRT-P）的脉冲發生器？
FDA產品代碼為心臟節律器、起搏器、可植入式，具有心臟節律同步功能（CRT-P）的產品代碼為NKE。
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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