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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 NamePROSTATRON PRAKTIS
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave therotherapy (tumt)
ApplicantEDAP TECHNOMED, INC.
PMA NumberP950014
Supplement NumberS019
Date Received11/02/1999
Decision Date11/05/1999
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) disabling the hardware that controls the minimum coolant temperature, and 2) modifying the maximum microwave power rating on the faceplate label.
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