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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
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nameprostate (bph) microwave apparatus
ApplicantEDAP TECHNOMED, INC.
PMA NumberP950014
Supplement NumberS013
Date Received03/04/1998
Decision Date03/10/1998
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for 1) the addition of a barcode identification label to the prostaprobe, and 2) modifications to the prostatron(tm) maxis and dual module configurations to require entry of the prostaprobe barcode information prior to treatment.
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