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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 NumberS009
Date Received11/21/2005
Decision Date03/15/2006
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR MULTIPLE DESIGN MODIFICATIONS WHICH AFFECT THE SAFETY AND EFFECTIVENESS OF THE PROLIEVE DEVICE.
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