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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 OPERATIONS AB CORETHERM SYSTEM MICROWAVE THERMOTHERAPY
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantProstalund AB
Scheelevagen 17
Se-223 63 Lund SE-223
PMA NumberP010055
Supplement NumberS003
Date Received11/22/2006
Decision Date12/21/2006
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
CHANGE IN THE MATERIAL USED IN THE TIP OF THE CATHETER COMPONENT OF THE DEVICE.
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