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FDA PMA

臨時非滾輪式左心輔助血泵

PMA 核准號:P140003 · 2026-06-15

申請人Abiomed, Inc.
決定日期2026-06-15
PMA 編號P140003
產品代碼OZD
器械分類3 類
醫療專科U
諮詢委員會履歷

器材摘要

Temporary non-roller type left heart support blood pump is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2026-06-15. The device is classified under product code OZD. It was reviewed by the CV advisory panel.

常見問題

What is the Temporary non-roller type left heart support blood pump?

Temporary non-roller type left heart support blood pump is a medical device that received FDA 510(k) clearance on 2026-06-15. The listed applicant is Abiomed, Inc..

When did Temporary non-roller type left heart support blood pump receive FDA 510(k) clearance?

The clearance date for Temporary non-roller type left heart support blood pump can be found in the official FDA records.

Who is the listed applicant for Temporary non-roller type left heart support blood pump?

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

What is the FDA product code for Temporary non-roller type left heart support blood pump?

The FDA product code for Temporary non-roller type left heart support blood pump is OZD.

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官方來源

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