植入式電氣設備，用於治療便失禁
PMA 核准號：P190006 · 2026-08-07
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決定日期2026-08-07
PMA 編號P190006
產品代碼QON
器械分類3 類
醫療專科G
法規編號21 CFR 8
諮詢委員會GU
器材摘要
Implanted electrical device intended for treatment of fecal incontinence is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2026-08-07. The device is classified under product code QON. It was reviewed by the GU advisory panel.
常見問題
What is the Implanted electrical device intended for treatment of fecal incontinence?
Implanted electrical device intended for treatment of fecal incontinence is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Boston Scientific Corporation.
When did Implanted electrical device intended for treatment of fecal incontinence receive FDA 510(k) clearance?
The clearance date for Implanted electrical device intended for treatment of fecal incontinence can be found in the official FDA records.
誰是為治療便失禁而設計的植入式電氣設備的登記申請人？
FDA 510(k) 記錄中將波士頓科學公司列為申請人。這並不單獨確立設備製造商。
FDA產品代碼是什麼？針對治療大腸失禁的植入式電氣設備？
FDA產品代碼為用於治療大腸失禁的植入式電氣設備為QON。
相關臨床試驗
相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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