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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.
 
DeviceCELSION PROLIEVE 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 NumberS002
Date Received08/18/2004
Decision Date09/17/2004
Product Code MEQ 
Advisory Committee Gastroenterology/Urology
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR SOFTWARE MODIFICATIONS INCLUDING ADJUSTMENT OF TOLERANCE LIMITS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME PROLIEVE THERMODILATION SYSTEM (PROLIEVE). PROLIEVE IS A TRANSURETHRAL MICROWAVE THERAPY DEVICE THAT PROVIDES A NON-SURGICAL, MINIMALLY INVASIVE PROCEDURE FOR THE TREATMENT OF SYMPTOMATIC BPH IN MEN WITH A PROSTATE SIZE OF 20 TO 80 GRAMS, A PROSTATIC URETHRA LENGTH OF 1.2 TO 5.5 CM AND IN WHOM DRUG THERAPY (E.G., PROSCAR) IS TYPICALLY INDICATED.
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