Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROSTATRON
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP950014
Supplement NumberS023
Date Received09/30/2004
Decision Date02/18/2005
Withdrawal Date 12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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.
-
-