PMA P950014S023

Device: PROSTATRON
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S023
Product code: MEQ
Decision date: 2005-02-18
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Approval order statement: APPROVAL FOR MODIFICATION OF THE PROSTATRON LABELING REGARDING THE TREATMENT OF PATIENTS 1) WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS), 2) IN URINARY RETENTION, AND 3) WITH MEDIAN PROSTATIC LOBES.

Current openFDA PMA Record#

Device: PROSTATRON
Applicant: Urologix, Inc.
PMA number: P950014
Supplement: S023
Product code: MEQ
Generic name: System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Decision date: 2005-02-18
Decision code: APPR
Date received: 2004-09-30
Supplement type: Normal 180 Day Track
Supplement reason: Labeling Change - Indications/instructions/shelf life/tradename
Approval order statement: APPROVAL FOR MODIFICATION OF THE PROSTATRON LABELING REGARDING THE TREATMENT OF PATIENTS 1) WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS), 2) IN URINARY RETENTION, AND 3) WITH MEDIAN PROSTATIC LOBES.