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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTARGIS (T3) SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUROLOGIX, INC.
PMA NumberP970008
Date Received02/24/1997
Decision Date08/22/1997
Product Code
MEQ[ Registered Establishments with MEQ ]
Docket Number 97M-0457
Notice Date 11/20/1997
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the t3(r) targeted transurethral thermoablation system: model 4000. This device is indicated to relieve symptoms associated with benign prostatic hyperplasia (bph) and is indicated for men with prostatic lengths of 30 to 50 millimeters.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 
S007 S008 S009 S010 S011 S012 
S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 
S025 S026 S027 S028 S029 S030 
S031 S033 S034 S035 S036 S037 
S038 S039 S040 S041 S042 S043 
S044 S045 S046 S047 S048 S049 
S050 S051 S052 S053 S055 S056 
S058 S059 S060 S061 S062 S063 
-
-