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ProACT Adjustable Continence Therapy for Men

by Uromedica Inc PMA

Active United States

PMA P130018

Overview

The ProACT Adjustable Continence Therapy for Men is a mechanical and hydraulic incontinence device designed to assist with bladder control. It is indicated for the treatment of adult men suffering from stress incontinence caused by intrinsic sphincter deficiency that has persisted for at least twelve months.

This therapy is intended for patients who have undergone radical prostatectomy or transurethral resection of the prostate and have not responded adequately to conservative treatment options. The device is subject to FDA PMA authorization under regulation number 876.5280.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP130018 Date24 Nov 2015ApprovedStatusActive

Coverage

1 jurisdiction

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

United States — FDA PMA Active

Recalls

2 recalls · FDA

    • Terminated Z-0458-2022 FDA Class II initiated 22 Nov 2021

    The U-channel sheaths may cause damage to ProACT implant devices when the devices are passed through the sheath during a ProACT implantation procedure.

    • Terminated Z-1808-2020 FDA Class II initiated 10 Apr 2019 via P130018, on the same PMA

    Potential issue with the manufacture and inspection of U-channel sheaths in Implantation Instruments Sets. Affected U-channel sheaths may be more likely to cause damage to ProACT implant devices when passes through the sheaths.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

PMA

Generic Name
Device, incontinence, mechanical/hydraulic
FDA applicant
Uromedica, Inc.
PMA Number
FDA Product Code
EZY
Device Class
Class III
Regulation
21 CFR Part 876.5280
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

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Questions

  • What is the primary indication for the ProACT system?

    The ProACT system is indicated for adult men experiencing stress incontinence resulting from intrinsic sphincter deficiency, specifically following procedures such as radical prostatectomy or transurethral resection of the prostate.

  • Who is a candidate for this therapy?

    Candidates are adult men who have experienced stress incontinence for at least twelve months and have failed to achieve adequate results through conservative therapy methods.

  • How is the ProACT device classified?

    The ProACT is classified as a mechanical and hydraulic incontinence device, regulated under the FDA PMA process as a class 3 medical device.