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Urologix Prostatron System

by Urologix, Inc.

PMA P950014

Urologix Prostatron System is a Class III device made by Urologix, Inc., approved under FDA PMA P950014 on 3 May 1996, withdrawn as of 6 Oct 2026. One FDA recall is linked to it.

Withdrawn Withdrawn in United States.

Was authorized under PMA, withdrawn

Ended

Withdrawn 3 May 1996

PMA

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA PMA, synced 6 Oct 2026.

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPWD Approval withdrawn NumberP950014 Date3 May 1996Approval withdrawnStatusWithdrawn

Official records

Recalls

1 recall · FDA

    • Terminated Z-0345-04 FDA Unclassified (pre-2012) initiated 10 Dec 2003

    During treatments, using the Prostatron units, the devices' Temperature Sensing System may change the rectal temperature reading by up to 2 degrees Celsius and may briefly delay updates to the rectal temperature reading.

Timeline

2 dated events

  1. Approved FDA PMA P950014
  2. Recall initiated FDA recalls Z-0345-04

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA PMA Withdrawn

Specification

PMA

Trade name
Prostatron
Generic name
System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
PMA number
FDA product code
MEQ
Device class
Class III
Advisory committee
Gastroenterology, Urology
FDA decision
APWD Approval withdrawn

Similar devices

Other devices filed under FDA product code MEQ (System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy).

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