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. |
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Device | UROLOGIX TARGIS SYSTEM |
Generic Name | System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy |
Applicant | Urologix, LLC 14405 21ST AVENUE N. MINNEAPOLIS, MN 55447-2000 |
PMA Number | P970008 |
Supplement Number | S018 |
Date Received | 12/03/2001 |
Decision Date | 09/04/2002 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR A CHANGE FROM THE STANDARD ANTENNA (2.8 CM IN LENGTH) TO A SHORTENED VERSION (2.0 CM IN LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM, AND IS INTENDED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASMIA (BPH), AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 2.5 TO 3.5 CM. |
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