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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTMX-2000 BPH THERMOTHERAPY SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy system
ApplicantAMERICAN MEDICAL SYSTEMS, INC.
PMA NumberP000043
Date Received10/16/2000
Decision Date06/29/2001
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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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