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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 MICROWAVE THERMOTHERAPY FOR BPH
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantPROSTALUND AB
SCHEELEVAGEN 17
SE-223 63 LUND SE-22-223
PMA NumberP010055
Supplement NumberS001
Date Received07/30/2004
Decision Date07/07/2005
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR TECHNOLOGICAL MODIFICATIONS TO THE CORETHERM SYSTEM TO COMPLY WITH THE NEW EDITION OF IEC 6061-1-2 "MEDICAL ELECTRICAL EQUIPMENT - PART1: GENERAL REQUIREMENTS FOR SAFETY; ELECTROMAGNETIC COMPATIBILITY REQUIREMENTS AND TESTS" (2ND EDITION, 2001).
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