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FDA PMA

設備,失禁,機械/水壓

PMA 核准號:P000053 · 2026-09-14

決定日期2026-09-14
PMA 編號P000053
產品代碼EZY
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

Device, incontinence, mechanical/hydraulic 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 EZY. It was reviewed by the GU advisory panel.

常見問題

What is the Device, incontinence, mechanical/hydraulic?

Device, incontinence, mechanical/hydraulic is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Boston Scientific Corp.

When did Device, incontinence, mechanical/hydraulic receive FDA 510(k) clearance?

The clearance date for Device, incontinence, mechanical/hydraulic can be found in the official FDA records.

Who is the listed applicant for Device, incontinence, mechanical/hydraulic?

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 Device, incontinence, mechanical/hydraulic?

The FDA product code for Device, incontinence, mechanical/hydraulic is EZY.

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