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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
Marlboro, MA 01752
PMA NumberP000043
Supplement NumberS001
Date Received12/20/2001
Decision Date05/23/2002
Withdrawal Date12/20/2016
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR A NEW MANUFACTURING SITE LOCATED AT MANUFACTURING AND RESEARCH, INC., TUCSON, ARIZONA. THE RX-200 APPLICATOR WILL BE MANUFACTURED AT THIS FACILITY.
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