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Axonics Sacral Neuromodulation System

by Boston Scientific 2 variants

PMA P180046

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

PMA P180046↗

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 NumberP180046 Date13 Nov 2019ApprovedStatusActive

Official records

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0198-2027 FDA Not yet classified initiated 15 Jul 2024

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

Timeline

2 dated events

  1. Approved FDA PMA P180046
  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  • Withdrawn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
Stimulator, electrical, implantable, for incontinence
FDA applicant
Boston Scientific Corporation
PMA number
FDA product code
EZW
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 implantable electrical stimulator for incontinence, as defined by its generic name and device classification. It is indicated for the treatment of urinary retention and the symptoms of overactive bladder, including urinary urge incontinence and significant symptoms of urgency-frequency alone or in combination, in patients who have failed or could not tolerate more conservative treatments.

The system is supplied as an implantable device and is intended for use in clinical settings under physician supervision. It has received FDA PMA approval (P180046) and is classified as a Class III device. No information regarding sterility, single-use or reusable status, MRI safety, sizes, or storage is provided in the source data.

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