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FDA PMA

支氣管熱塑術系統

PMA 核准號:P080032 · 2022-02-18

決定日期2022-02-18
PMA 編號P080032
產品代碼OOY
器械分類3 類
醫療專科U
諮詢委員會AN

器材摘要

Bronchial thermoplasty system is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2022-02-18. The device is classified under product code OOY. It was reviewed by the AN advisory panel.

常見問題

What is the Bronchial thermoplasty system?

Bronchial thermoplasty system is a medical device that received FDA 510(k) clearance on 2022-02-18. The listed applicant is Boston Scientific Corp.

When did Bronchial thermoplasty system receive FDA 510(k) clearance?

The clearance date for Bronchial thermoplasty system can be found in the official FDA records.

Who is the listed applicant for Bronchial thermoplasty system?

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

What is the FDA product code for Bronchial thermoplasty system?

The FDA product code for Bronchial thermoplasty system is OOY.

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官方來源

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