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.
 
DeviceUROLOGIX PROSTATRON SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21st Ave. N
Plymouth, MN 55447
PMA NumberP950014
Supplement NumberS026
Date Received03/14/2008
Decision Date07/16/2008
Withdrawal Date12/30/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR DESIGN MODIFICATIONS WHICH INCLUDE A NEW CATHETER TIP MATERIAL, RED MARK ADHESIVE, BONDING ADHESIVES, INJECTION MOLD FOR MANUFACTURING THE CATHETER TIP, AND A NEW STERILE BALLOON INFLATION STOPCOCK. THE PRODUCTION OF THE PROSTAPROBE TYPE II, SILICONE, BLUE TREATMENT CATHETER (PART NUMBER 410053-004) WILL BE MANUFACTURED AT MEDTECH COSTA RICA, SA, COSTA RICA, CENTRAL AMERICA.
-
-