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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 AND PROSTALAND CORETHERM ACCESSORIES
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantPROSTALUND AB
SCHEELEVAGEN 17
SE-223 63 LUND SE-22-223
PMA NumberP010055
Supplement NumberS009
Date Received02/21/2014
Decision Date07/30/2014
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
Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED AT ORIFICE MEDICAL AB IN YSTAD, SWEDEN.
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