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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 THERMOTHERAPY SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy system
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000043
Supplement NumberS020
Date Received11/23/2007
Decision Date12/17/2007
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Transfer of the label generation process for a catheter from the ams minnetonka facility to mri medical, in tucson, arizona.
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