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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
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 NumberS001
Date Received07/30/2004
Decision Date07/07/2005
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
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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