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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DevicePROLIEVE THERMODILATATION SYSTEM
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantMedifocus, Inc.
10240 Old Columbia Rd.
Suite G
Columbia, MD 21046
PMA NumberP030006
Supplement NumberS001
Date Received03/11/2004
Decision Date04/15/2004
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL OF THE POST-APPROVAL STUDY FOR THE DEVICE.
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