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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 CATHETER
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantProstalund AB
Scheelevagen 17
Se-223 63 Lund SE-223
PMA NumberP010055
Supplement NumberS004
Date Received05/25/2007
Decision Date06/19/2007
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 IP-SEAL OF THE DEVICE.
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