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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTMX-2000 BPH THERMOTHERAPY SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP000043
Supplement NumberS004
Date Received08/02/2002
Decision Date08/22/2002
Withdrawal Date 12/20/2016
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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.
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