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FDA PMA

心臟節律器,單心房,感測驅動,可植入式

PMA 核准號:P970013 · 2026-07-21

決定日期2026-07-21
PMA 編號P970013
產品代碼LWO
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Pulse-generator, single chamber, sensor driven, implantable 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 LWO. It was reviewed by the CV advisory panel.

常見問題

What is the Pulse-generator, single chamber, sensor driven, implantable?

Pulse-generator, single chamber, sensor driven, implantable is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is ABBOTT MEDICAL.

When did Pulse-generator, single chamber, sensor driven, implantable receive FDA 510(k) clearance?

The clearance date for Pulse-generator, single chamber, sensor driven, implantable can be found in the official FDA records.

誰是 Pulse-generator, single chamber, sensor driven, implantable 的登記申請人?

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 Pulse-generator, single chamber, sensor driven, implantable 的產品是什麼?

FDA產品代碼,針對心臟節律器,單心房,感測驅動,植入式,為LWO。

相關臨床試驗

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官方來源

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