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Virtis Sacral Neuromodulation System

by Cirtec Medical Corporation United States PMA

PMA P170001 Product code EZW

Overview

The Virtis Sacral Neuromodulation System is an implantable electrical stimulator classified as a stimulator, electrical, implantable, for incontinence. It is designed to modulate sacral nerve activity to treat urinary retention and symptoms of overactive bladder, including urinary urge incontinence and urgency-frequency, in patients who have not responded to or tolerated conservative therapies. This device operates by delivering controlled electrical pulses to the sacral nerves via an implanted pulse generator and leads.

The system is supplied as a sterile, implantable medical device and is intended for surgical implantation by qualified healthcare professionals. It is regulated under FDA_PMA (PMA Number: P170001) and falls under device class 3 with regulation number 876.5270. The system includes an implantable pulse generator and leads, with multiple registration numbers (e.g., 3002968685) for tracking and compliance. Storage and handling must adhere to sterile medical device protocols to ensure proper functionality and patient safety.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP170001 Date11 Jan 2023ApprovedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA PMA Active

Recalls: none on record (FDA, checked 6 Oct 2026)

Specification

PMA · synced 6 Oct 2026

Generic Name
Stimulator, electrical, implantable, for incontinence
PMA Number
FDA Product Code
EZW
Device Class
Class III
Regulation
21 CFR Part 876.5270
Advisory Committee
Gastroenterology, Urology
FDA Decision
APPR Approved

Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA PMA P170001 23 fields · synced 6 Oct 2026