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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 NamePROLIEVE THERMODILATATION SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy(tumt) device
ApplicantCELSION CORP.
PMA NumberP030006
Supplement NumberS011
Date Received06/26/2006
Decision Date08/10/2006
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 manufacturing changes to correct the inner manifold bond of the catheter and to confirm dimensions of tubing used with the heat exchanger.
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