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Axonics Sacral Neuromodulation System

by Boston Scientific 2 variants

PMA P190006

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

Recall on shared PMA P190006; other models may be affected

Documents

PMA P190006↗

FDA record

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP190006 Date6 Sep 2019ApprovedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0198-2027 FDA Not yet classified initiated 15 Jul 2024 on shared PMA P190006

    Retroactively Reported: 10mL luer lock syringes included in kit may leak , break or experience other issues that may pose a risk to users.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

2 dated events

  1. Approved FDA PMA P190006
  2. Recall initiated FDA recalls Z-0198-2027

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA PMA Active

Specification

PMA

Generic name
Implanted electrical device intended for treatment of fecal incontinence
FDA applicant
Boston Scientific Corporation
PMA number
FDA product code
QON
Device class
Class III
Regulation
21 CFR Part 876.5270
Advisory committee
Gastroenterology, Urology
FDA decision
APPR Approved

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Axonics Sacral Neuromodulation System is an implanted electrical device intended for the treatment of chronic fecal incontinence in patients who have failed or are not candidates for more conservative treatments. This system delivers electrical stimulation to the sacral nerves to help restore normal bowel function.

The device is supplied as a single-use, implantable system and requires specific storage conditions. It has received FDA PMA approval and is classified under product code QON for regulation number 876.5270, with registration numbers including 3002968685, 3004593495, and others as specified.

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