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FDA PMA

除颤器,植入式,雙腔

PMA 核准號:P980049 · 2025-11-25

決定日期2025-11-25
PMA 編號P980049
產品代碼MRM
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is the device name listed in this FDA 510(k) record. The listed applicant is MicroPort CRM USA, Inc.. It received FDA 510(k) clearance on 2025-11-25. The device is classified under product code MRM. It was reviewed by the CV advisory panel.

常見問題

What is the DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER?

DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER is a medical device that received FDA 510(k) clearance on 2025-11-25. The listed applicant is MicroPort CRM USA, Inc..

When did DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER receive FDA 510(k) clearance?

The clearance date for DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER can be found in the official FDA records.

誰是列出的DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER的申請人?

The FDA 510(k) record lists MicroPort CRM USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼為DEFIBRILLATOR, IMPLANTABLE, DUAL-CHAMBER的是什麼?

FDA產品代碼為植入式雙心腔除颤器的代碼是MRM。

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官方來源

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