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FDA PMA

藥物釋放式永久性左心室(lv)起搏器電極

PMA 核准號:P050046 · 2021-09-24

申請人Guidant Corp.
決定日期2021-09-24
PMA 編號P050046
產品代碼OJX
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Drug eluting permanent left ventricular (lv) pacemaker electrode is the device name listed in this FDA 510(k) record. The listed applicant is Guidant Corp.. It received FDA 510(k) clearance on 2021-09-24. The device is classified under product code OJX. It was reviewed by the CV advisory panel.

常見問題

What is the Drug eluting permanent left ventricular (lv) pacemaker electrode?

Drug eluting permanent left ventricular (lv) pacemaker electrode is a medical device that received FDA 510(k) clearance on 2021-09-24. The listed applicant is Guidant Corp..

When did Drug eluting permanent left ventricular (lv) pacemaker electrode receive FDA 510(k) clearance?

The clearance date for Drug eluting permanent left ventricular (lv) pacemaker electrode can be found in the official FDA records.

Who is the listed applicant for Drug eluting permanent left ventricular (lv) pacemaker electrode?

The FDA 510(k) record lists Guidant Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Drug eluting permanent left ventricular (lv) pacemaker electrode?

The FDA product code for Drug eluting permanent left ventricular (lv) pacemaker electrode is OJX.

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官方來源

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