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FDA PMA

針對前列腺的永久性或半永久性尿道支架

PMA 核准號:P250007 · 2025-12-11

申請人Zenflow, Inc.
決定日期2025-12-11
PMA 編號P250007
產品代碼MER
器械分類3 類
醫療專科U
諮詢委員會GU

器材摘要

STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT is the device name listed in this FDA 510(k) record. The listed applicant is Zenflow, Inc.. It received FDA 510(k) clearance on 2025-12-11. The device is classified under product code MER. It was reviewed by the GU advisory panel.

常見問題

What is the STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT?

STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT is a medical device that received FDA 510(k) clearance on 2025-12-11. The listed applicant is Zenflow, Inc..

When did STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT receive FDA 510(k) clearance?

The clearance date for STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT can be found in the official FDA records.

誰是STENT, URETHRAL, PROSTATIC, 永久或半永久類型的列名申請人?

The FDA 510(k) record lists Zenflow, Inc. as the applicant. This does not by itself establish the device manufacturer.

FDA產品代碼為STENT, URETHRAL, PROSTATIC, 永久或半永久型的是什麼?

FDA產品代碼對於STENT, URETHRAL, PROSTATIC, 永久或半永久型的是MER。

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官方來源

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