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FDA PMA

去颤器,自動植入式心室去極化器,具有心臟節律重整功能(CRT-D)

PMA 核准號:P880006 · 2016-02-12

決定日期2016-02-12
PMA 編號P880006
產品代碼NIK
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) is the device name listed in this FDA 510(k) record. The listed applicant is St. Jude Medical, Inc.. It received FDA 510(k) clearance on 2016-02-12. The device is classified under product code NIK. It was reviewed by the CV advisory panel.

常見問題

What is the Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)?

Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) is a medical device that received FDA 510(k) clearance on 2016-02-12. The listed applicant is St. Jude Medical, Inc..

When did Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) receive FDA 510(k) clearance?

The clearance date for Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) can be found in the official FDA records.

誰是自動植入式心臟去節律器(CRT-D)的登記申請人?

The FDA 510(k) record lists St. Jude Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼是什麼?對於具有心臟節律重整功能(CRT-D)的自動植入式心臟轉換器除蟲器?

FDA產品代碼為自動植入式心臟起搏器,具有心臟節律重整功能(CRT-D)的除颤器為NIK。

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