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 FOR THE TREATMENT OF BPH |
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 | S036 |
Date Received | 01/31/2008 |
Decision Date | 03/31/2008 |
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 CHANGES TO THE MATERIALS, COLOR, ANTENNA DESIGN, COOLANT PATH FUNCTIONS AND DESIGN OF THE COOLED THERMOCATH CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CTC ADVANCE AND IS INDICATED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 3.5 ? 5.0 CM (MODEL NUMBER TC1121C) OR 4.5+ CM (MODEL NUMBER TF1221C). |
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