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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.
 
DevicePRAKTIS
Generic NameSystem, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
ApplicantUrologix, Inc.
14405 21ST AVENUE N.
MINNEAPOLIS, MN 55447-2000
PMA NumberP950014
Supplement NumberS011
Date Received12/31/1997
Decision Date03/13/1998
Withdrawal Date 12/30/2014
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
Approval Order Statement  
Approval for a new hardware and software configuration of the Prostatron(TM). The device, as modified, will be marketed under the trade name Prostatron(TM) Praktis and is indicated as a non-surgical treatment alternative to transurethral resection of the prostate (TURP) for the treatment of symptomatic benign prostatic hyperplasia (BPH). It is intended that the Prostatron(TM) Praktis deliver a complete thermal therapy treatment during a single treatment session. The Prostatron(TM) Praktis is available with two treatment protocols, each requiring a unique treatment catheter. Protocol 2.0, which uses the standard Prostaprobe (Black) treatment catheter, is indicated for patients with prostatic lengths of 35 to 50 mm. The higher energy Protocol 2.5, which uses the Prostaprobe (Blue) treatment catheter, is indicated for patients with prostatic lengths of 25 to 50 mm in whom the benefits of obstructive improvement outweigh the attendant risks.
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