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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.
 
DeviceTHERMATIX OFFICE THERMO THERAPY SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantBoston Scientific Corp.
100 Boston Scientific Way
Marlborough, MA 01752
PMA NumberP000043
Supplement NumberS013
Date Received02/07/2006
Decision Date02/27/2006
Withdrawal Date 12/20/2016
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A REVISION OF CATHETER LABELS AND THE ADDITION OF AN ENHANCED LABEL TO THE EXISTING LABELED STOCK.
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