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FDA PMA

人工陰莖,可充氣

PMA 核准號:N970012 · 2026-09-14

決定日期2026-09-14
PMA 編號N970012
產品代碼JCW
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

Prosthesis, penis, inflatable is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 2026-09-14. The device is classified under product code JCW. It was reviewed by the GU advisory panel.

常見問題

What is the Prosthesis, penis, inflatable?

Prosthesis, penis, inflatable is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Boston Scientific Corp.

When did Prosthesis, penis, inflatable receive FDA 510(k) clearance?

The clearance date for Prosthesis, penis, inflatable can be found in the official FDA records.

Who is the listed applicant for Prosthesis, penis, inflatable?

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

What is the FDA product code for Prosthesis, penis, inflatable?

The FDA product code for Prosthesis, penis, inflatable is JCW.

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

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