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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 NameTMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy system
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000043
Supplement NumberS015
Date Received07/19/2006
Decision Date12/15/2006
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the labeling to incorporate the results of the 5-year postapproval study. The device, as modified, will be marketed under the trade name tmx-2000 thermatrx office thermo therapy system and is indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men who have a minimum prostatic urethra length of 25 mm and a total prostate volume between 30 and 100 cc.
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