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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 ROAD
SUITE G
COLUMBIA, MD 21046
PMA NumberP030006
Supplement NumberS015
Date Received06/14/2007
Decision Date07/10/2007
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
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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