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FDA PMA

AGENT,BULKING,注射用胃腸泌尿科用

PMA 核准號:P170023 · 2026-07-01

決定日期2026-07-01
PMA 編號P170023
產品代碼LNM
器械分類3 類
醫療專科U
諮詢委員會GU

器材摘要

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE 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 2026-07-01. The device is classified under product code LNM. It was reviewed by the GU advisory panel.

常見問題

What is the AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE?

AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is Boston Scientific Corporation.

When did AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE receive FDA 510(k) clearance?

The clearance date for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE can be found in the official FDA records.

Who is the listed applicant for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE?

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。

What is the FDA product code for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE?

The FDA product code for AGENT, BULKING, INJECTABLE FOR GASTRO-UROLOGY USE is LNM.

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官方來源

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