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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
ApplicantBOSTON SCIENTIFIC CORP.
PMA NumberP030006
Supplement NumberS015
Date Received06/14/2007
Decision Date07/10/2007
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Six changes: 1) revised work in progress management procedure; 2) a process document change; 3) change in the frequency of a maintenance schedule; 4) change in the identification of a part; 5) change in the tolerance of a part; and 6) change in a subassembly test.
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