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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NamePROSTALUND CORETHERM SYSTEM MICROWAVE THERMOTHERAPY FOR BPH
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave/thermal therapy system
ApplicantPROSTALUND OPERATIONS AB
PMA NumberP010055
Supplement NumberS001
Date Received08/04/2004
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 - component
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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