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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
Classification Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Generic Namesystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
Applicant
MEDIFOCUS, INC
10240 old columbia road
suite g
columbia, MD 21046
PMA NumberP030006
Supplement NumberS012
Date Received11/21/2006
Decision Date12/22/2006
Product Code
MEQ[ Registered Establishments with MEQ ]
Advisory Committee Gastroenterology/Urology
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR REMOVAL OF A CAPACITOR FROM THE COMPUTER BOARD INPUT LINES TO ENABLE THE TACHOMETER READOUT TO DISPLAY PUMP SPEED AND MODIFICATION OF THE CAPACITORS FROM THE COMPUTER INPUT/OUTPUT BOARD TO DISPLAY OF TEMPERATURE DATA.
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