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 has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTARGIS (T3) SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, LLC
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP970008
Date Received02/24/1997
Decision Date08/22/1997
Product Code MEQ 
Docket Number 97M-0457
Notice Date 11/20/1997
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Supplements: S059  S055 S012 S013 S014 S015 S016 S024 S060 S030 S033 
S021 S022 S045 S006 S007 S008 S017 S001 S002 S003 S004 S005 
S039 S052 S051 S034 S027 S028 S029 S020 S009 S010 S011 S056 
S058 S062 S063 S064 S065 S061 S023 S035 S036 S037 S038 S042 
S046 S047 S048 S040 S041 S018 S019 S025 S026 S043 S049 S050 
S053 S031 S044 
-
-