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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
Trade NameUROLOGIX PROSTATRON SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave therotherapy (tumt)
ApplicantUROLOGIX, INC.
PMA NumberP950014
Supplement NumberS026
Date Received04/04/2008
Decision Date07/16/2008
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
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.
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