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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.
 
DevicePROSTATRON
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
Urologix, Inc.
14405 21st avenue n.
minneapolis, MN 55447-2000
PMA NumberP950014
Supplement NumberS024
Date Received01/19/2005
Decision Date02/23/2005
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to change location balloon material from latex to silicone, to change the method of attaching the location balloon due to the new material, and to remove the current latex sensitivity caution and other references to latex in the labeling.
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