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FDA PMA

Implanted electrical device intended for treatment of fecal incontinence

Número do PMA: P080025 · 2026-09-14

RequerenteMedtronic Neuromodulation
Data da decisão2026-09-14
Número PMAP080025
Código do produtoQON
Classe do DispositivoClasse 3
Especialidade MédicaG
Número da Regulamentação21 CFR 8
Comité consultivoGU

Resumo do dispositivo

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.

Perguntas frequentes

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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Fonte oficial

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