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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 NameCORETHERM SYSTEM MICROWAVE THERMOTHERAPY
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave/thermal therapy system
ApplicantPROSTALUND OPERATIONS AB
PMA NumberP010055
Supplement NumberS002
Date Received09/30/2004
Decision Date11/05/2004
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at mri manufacturing and research inc (mri medical), 4700 s. Overland drive, tucson, arizona 85714-3430. Mri medical will duplicate manufacture the modified prostalund feedback treatment (plft) catheter.
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