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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.
 
DeviceCORETHERM 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 NumberS006
Date Received04/02/2009
Decision Date06/08/2009
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
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 MANUFACTURING SITE LOCATED AT CENOVA INNOVATION AND PRODUCTION AB IN MJOLBY, SWEDEN, WHERE CATHETER PACKAGING WILL BE PERFORMED.
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