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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 TECHNOMED, INC.
PMA NumberP950014
Supplement NumberS009
Date Received09/18/1997
Decision Date09/24/1997
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the following changes in intended to minimize the risk of prostaprobe balloon deflation difficulty: 1)modification of the prostaprobe manufacturing procedures, and 2) addition of a labeling precaution.
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