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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.
 
DevicePROSTALUND CORETHERM SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantPROSTALUND AB
SCHEELEVAGEN 17
SE-223 63 LUND SE-22-223
PMA NumberP010055
Supplement NumberS007
Date Received09/09/2009
Decision Date01/29/2014
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR MODIFICATION OF THE INDICATIONS FOR USE AND ASSOCIATED MODIFICATIONS TO THE CATHETER, ANTENNA, AND TEMPERATURE PROBE FOR PATIENTS WITH PROSTATES SMALLER THAN CURRENTLY INDICATED. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CORETHERMACCESSORIES FOR SMALL PROSTATES AND IS INDICATED FOR USE TOGETHER WITH PROSTALUND CORETHERM /SE IN PATIENTS WITH GLANDS SIZE 20-50G AND WITH A PROSTATE LENGTH ¿25 MM.
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