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ProVee System for BPH

by Proverum, Ltd.

PMA P250011

Active United States

PMA

Valid until

No expiry

PMA approval is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

PMA P250011↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA PMA, synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved NumberP250011 Date9 Dec 2025ApprovedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Active

Specification

PMA

Generic Name
STENT, URETHRAL, PROSTATIC, PERMANENT OR SEMI-PERMANENT
PMA Number
FDA Product Code
MER
Device Class
Class III
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 ProVee System for BPH is a urethral stent intended for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men. It is designed for men with prostatic urethral lengths greater than or equal to 3.75 cm and prostatic volumes between 30 and 80 cc. The system is classified as a permanent or semi-permanent prostatic urethral stent. The ProVee System for BPH is a medical device used to treat BPH symptoms, providing relief for patients with this condition.

The ProVee System for BPH is supplied by Proverum, Ltd. and has received FDA PMA authorization. The device is used in the field of urology and gastroenterology, and is classified under the product code MER. The system is designed for use in men with specific prostatic urethral lengths and volumes, and is intended to provide a permanent or semi-permanent solution for treating BPH symptoms.

Other devices from Proverum, Ltd.

Questions

AI-generated answers, 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.

  • What is the ProVee System for BPH intended for?

    The ProVee System for BPH is intended for the treatment of obstructive lower urinary tract symptoms secondary to benign prostatic hyperplasia (BPH) in men with prostatic urethral lengths greater than or equal to 3.75 cm and prostatic volumes between 30 and 80 cc.

  • What type of device is the ProVee System for BPH?

    The ProVee System for BPH is a urethral stent, specifically a permanent or semi-permanent prostatic urethral stent.

  • What regulatory authorization has the ProVee System for BPH received?

    The ProVee System for BPH has received FDA PMA authorization, as indicated by the PMA number P250011.