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 TARGIS SYSTEM FOR THE TREATMENT OF BPH
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, LLC
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP970008
Supplement NumberS036
Date Received01/31/2008
Decision Date03/31/2008
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE MATERIALS, COLOR, ANTENNA DESIGN, COOLANT PATH FUNCTIONS AND DESIGN OF THE COOLED THERMOCATH CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CTC ADVANCE AND IS INDICATED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 3.5 ? 5.0 CM (MODEL NUMBER TC1121C) OR 4.5+ CM (MODEL NUMBER TF1221C).
-
-