• 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 | Inspections

New Search Back to Search Results
Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametargeted transurethral thermoablation for benign prostatic hyperplasia bph
PMA NumberP970008
Supplement NumberS025
Date Received02/01/2005
Decision Date02/15/2005
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes to the device: 1) the change of the insertion tip and adhesive of the cooled thermocath microwave delivery system (ctc mds) to increase to the flexibility of the catheter; 2) the change of the insertion tip and adhesive of the targis microwave delivery system to the same catheter type as the ctc mds; and 3) the addition of texin 950 uv stabilized tubing for the shaft of the ctc catheter.