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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTMX-2000 BPH THERMOTHERAPY SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
Boston Scientific Corp.
100 boston scientific way
marlborough, MA 01752
PMA NumberP000043
Date Received10/16/2000
Decision Date06/29/2001
Withdrawal Date 12/20/2016
Product Code
MEQ[ Registered Establishments with MEQ ]
Docket Number 01M-0296
Notice Date 07/16/2001
Advisory Committee Gastroenterology/Urology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR THE TMX-2000(TM) BPH THERMOTHERAPY SYSTEM. THE DEVICE IS INDICATED AS A NON-SURGICAL DEVICE FOR THE TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WHO HAVE A MINIMUM PROSTATIC URETHRA LENGTH OF 30 MM AND A TOTAL PROSTATE VOLUME BETWEEN 30 AND 100 CC.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S022 
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