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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 NamePROSTATRON (TM) SYSTEM DISPOSABLE TREATMENT APPLICATOR
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave therotherapy (tumt)
ApplicantUROLOGIX, INC.
PMA NumberP950014
Supplement NumberS021
Date Received07/02/2001
Decision Date09/19/2001
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 a new manufacturing site located at venusa de mexico s. A. De c. V, chihuahua, mexico, in which the prostatron disposable treatment applicator will be assembled. In addition, approval for a manufacturing facility located at venusa ltd. , el paso, texas, for the receipt, inspection, storage, and release of components and the quarantine of finished sterilized devices. Also, the applicator will be sterilized at griffith microscience, santa teresa, new mexico.
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