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FDA PMA

植入式,抗食道胃逆流

PMA 核准號:P250018 · 2026-08-20

決定日期2026-08-20
PMA 編號P250018
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 Implantica CE Reflux , Ltd.. It received FDA 510(k) clearance on 2026-08-20. 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 2026-08-20. The listed applicant is Implantica CE Reflux , Ltd..

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 Implantica CE Reflux , Ltd. 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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