人工乳房，非充氣式，內置，矽膠填充
PMA 核准號：P060028 · 2026-07-21
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決定日期2026-07-21
PMA 編號P060028
產品代碼FTR
器械分類3 類
醫療專科G
法規編號21 CFR 8
諮詢委員會SU
請提供完整的描述文本，以便我進行翻譯。
器材摘要
Prosthesis, breast, noninflatable, internal, silicone gel-filled is the device name listed in this FDA 510(k) record. The listed applicant is Mentor Worldwide, LLC. It received FDA 510(k) clearance on 2026-07-21. The device is classified under product code FTR. It was reviewed by the SU advisory panel.
常見問題
What is the Prosthesis, breast, noninflatable, internal, silicone gel-filled?
Prosthesis, breast, noninflatable, internal, silicone gel-filled is a medical device that received FDA 510(k) clearance on 2026-07-21. The listed applicant is Mentor Worldwide, LLC.
When did Prosthesis, breast, noninflatable, internal, silicone gel-filled receive FDA 510(k) clearance?
The clearance date for Prosthesis, breast, noninflatable, internal, silicone gel-filled can be found in the official FDA records.
誰是Prosthesis, breast, noninflatable, internal, silicone gel-filled的登記申請人？
The FDA 510(k) record lists Mentor Worldwide, LLC as the applicant. This does not by itself establish the device manufacturer.
FDA產品代碼為Prosthesis, breast, noninflatable, internal, silicone gel-filled是什麼？
FDA產品代碼，對於內部填充矽膠的不可充氣乳房假體為FTR。
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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