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 | S060 |
Date Received | 12/20/2011 |
Decision Date | 02/03/2012 |
Product Code |
MEQ |
Advisory Committee |
Gastroenterology/Urology |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR MINOR CHANGES TO THE SOFTWARE FOR THE TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000 AND ASSOCIATED CHANGES TO THE USER MANUAL. THE DEVICE,AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE RELIEF OF SYMPTOMS AND OBSTRUCTIONS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 2.5-3.5CM (SHORT ANTENNA), OR 3.0-5.0CM (STANDARD ANTENNA), OR 4.5+CM (LONG ANTENNA). |
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