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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
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nameprostate (bph) microwave apparatus
ApplicantEDAP INTERNATIONAL CORP.
PMA NumberP950014
Supplement NumberS006
Date Received04/07/1997
Decision Date11/24/1997
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changes to the prostatron(r) software program to include a high energy treatment protocol (using either the single or dual-module hardware configurations).
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