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FDA PMA

植入式,抗食道胃逆流

PMA 核准號:P100049 · 2026-01-16

申請人Torax Medical
決定日期2026-01-16
PMA 編號P100049
產品代碼LEI
器械分類3 類
醫療專科U
諮詢委員會GU

器材摘要

IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX is the device name listed in this FDA 510(k) record. The listed applicant is Torax Medical. It received FDA 510(k) clearance on 2026-01-16. The device is classified under product code LEI. It was reviewed by the GU advisory panel.

常見問題

What is the IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX?

IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX is a medical device that received FDA 510(k) clearance on 2026-01-16. The listed applicant is Torax Medical.

When did IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX receive FDA 510(k) clearance?

The clearance date for IMPLANT, ANTI-GASTROESOPHAGEAL REFLUX can be found in the official FDA records.

誰是IMPLANT, 防治胃食道逆流設備的登記申請人?

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

FDA產品代碼為IMPLANT, 防治胃食道逆流的是什麼?

FDA產品代碼對於植入式、抗胃食道逆流設備為LEI。

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官方來源

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