FDA PMA

Implanted electrical device intended for treatment of fecal incontinence

PMA番号：P080025 · 2026-09-14

申請者Medtronic Neuromodulation

決定日2026-09-14

PMA番号P080025

製品コードQON

デバイスクラスクラス3

診療科G

規制番号21 CFR 8

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

医療機器の概要

Implanted electrical device intended for treatment of fecal incontinence is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neuromodulation. It received FDA 510(k) clearance on 2026-09-14. The device is classified under product code QON. It was reviewed by the GU advisory panel.

よくある質問

What is the Implanted electrical device intended for treatment of fecal incontinence?

Implanted electrical device intended for treatment of fecal incontinence is a medical device that received FDA 510(k) clearance on 2026-09-14. The listed applicant is Medtronic Neuromodulation.

When did Implanted electrical device intended for treatment of fecal incontinence receive FDA 510(k) clearance?

The clearance date for Implanted electrical device intended for treatment of fecal incontinence can be found in the official FDA records.

Who is the listed applicant for Implanted electrical device intended for treatment of fecal incontinence?

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

What is the FDA product code for Implanted electrical device intended for treatment of fecal incontinence?

The FDA product code for Implanted electrical device intended for treatment of fecal incontinence is QON.

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医療機器の概要

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