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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, MAXIS AND PRAKTIS
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nameprostate (bph) microwave apparatus
ApplicantEDAP TECHNOMED, INC.
PMA NumberP950014
Supplement NumberS017
Date Received01/13/1999
Decision Date01/25/1999
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 minor changes to the design of the prostaprobe.
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