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FDA PMA

Implanted electrical device intended for treatment of fecal incontinence

PMA Number: P080025 · 2026-10-09

ApplicantMedtronic Neuromodulation
Decision Date2026-10-09
PMA NumberP080025
Product CodeQON
Device ClassClass 3
Medical SpecialtyG
Regulation Number21 CFR 8
Advisory CommitteeGU

Device Summary

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 2026-10-09. The device is classified under product code QON. It was reviewed by the GU advisory panel.

Frequently Asked Questions

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 2026-10-09. 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.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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