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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 NameTHERMATRX OFFICE THERMO THERAPY
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy system
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000043
Supplement NumberS016
Date Received09/22/2006
Decision Date10/13/2006
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: packager
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at mri manufacturing and research, inc. , tucson, arizona to conduct packaging and labeling for the rx-200 applicator (catheter).
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