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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 NumberS017
Date Received02/12/2008
Decision Date05/18/2009
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typenormal 180 day track
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a rectal temperature monitor which is disposable. The disposable rectal temperature monitor will be contract manufactured at phillips plastic corporation, short-run facility (phillips short-run) located in richmond, wisconsin.
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