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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 CATHETER AND HEAT EXCHANGER
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy(tumt) device
ApplicantCELSION CORP.
PMA NumberP030006
Supplement NumberS005
Date Received03/23/2005
Decision Date06/30/2005
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for accellent juarez (manufacturing site) located in, chihuahua, mexico; accellent el paso (warehouse) located in el paso, texas; and sterigenics international, inc. (sterilizer) located in santa teresa, new mexico.
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