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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
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
PROSTALUND AB
scheelevagen 17
se-223 63 lund SE-22-223
PMA NumberP010055
Supplement NumberS003
Date Received11/22/2006
Decision Date12/21/2006
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
CHANGE IN THE MATERIAL USED IN THE TIP OF THE CATHETER COMPONENT OF THE DEVICE.
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