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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 THERMODILITATION SYSTEM
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Nametransurethral microwave thermotherapy(tumt) device
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030006
Supplement NumberS018
Date Received06/05/2008
Decision Date10/16/2008
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the modifications to the porlieve¿ heat exchanger cartridge assembly method. The device, as modified, will be marketed under the trade name prolieve¿ thermodilitation system and is indicated for the treatment of symptomatic benign prostatic hyperplasia (bph) in men.
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