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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 NameTHERMATIX 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 NumberS013
Date Received02/07/2006
Decision Date02/27/2006
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Type Special Supplement
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a revision of catheter labels and the addition of an enhanced label to the existing labeled stock.
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