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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.
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
PMA NumberP000043
Supplement NumberS004
Date Received08/02/2002
Decision Date08/22/2002
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to remove the contraindication for patients with prostatic or bladder cancer, and add the precaution stating that the safety and effectiveness of the thermatrx tmx-2000 has not been established in patients with clinical or histological evidence of prostate or bladder cancer.