刺激器，電氣式，植入式，用於失禁
PMA 核准號：P180046 · 2026-08-07
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決定日期2026-08-07
PMA 編號P180046
產品代碼EZW
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
Stimulator, electrical, implantable, for 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 EZW. It was reviewed by the GU advisory panel.
常見問題
What is the Stimulator, electrical, implantable, for incontinence?
Stimulator, electrical, implantable, for incontinence is a medical device that received FDA 510(k) clearance on 2026-08-07. The listed applicant is Boston Scientific Corporation.
When did Stimulator, electrical, implantable, for incontinence receive FDA 510(k) clearance?
The clearance date for Stimulator, electrical, implantable, for incontinence can be found in the official FDA records.
誰是電氣植入式刺激器，用於失禁的登記申請人？
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產品代碼為何是電氣植入式刺激器，用於失禁？
FDA產品代碼為Stimulator, electrical, implantable, for incontinence的電刺激植入式尿失禁設備為EZW。
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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