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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 NameCELSION PROLIEVE THERMODILATATION SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy(tumt) device
ApplicantCELSION CORP.
PMA NumberP030006
Supplement NumberS002
Date Received08/18/2004
Decision Date09/17/2004
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for software modifications including adjustment of tolerance limits. The device, as modified, will be marketed under the trade name prolieve thermodilation system (prolieve). Prolieve is a transurethral microwave therapy device that provides a non-surgical, minimally invasive procedure for the treatment of symptomatic bph in men with a prostate size of 20 to 80 grams, a prostatic urethra length of 1. 2 to 5. 5 cm and in whom drug therapy (e. G. , proscar) is typically indicated.
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