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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 THERMATRX OFFICE THERMO THERAPY SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantBoston Scientific Corp
100 Boston Scientific Way
Marlboro, MA 01752
PMA NumberP000043
Supplement NumberS015
Date Received07/19/2006
Decision Date12/15/2006
Withdrawal Date12/20/2016
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR CHANGES TO THE LABELING TO INCORPORATE THE RESULTS OF THE 5-YEAR POSTAPPROVAL STUDY. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TMX-2000 THERMATRX OFFICE THERMO THERAPY SYSTEM AND IS INDICATED FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 25 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC.
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