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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 | S025 |
Date Received | 02/01/2005 |
Decision Date | 02/15/2005 |
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 |
Approval Order Statement APPROVAL FOR THE FOLLOWING CHANGES TO THE DEVICE: 1) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE COOLED THERMOCATH MICROWAVE DELIVERY SYSTEM (CTC MDS) TO INCREASE TO THE FLEXIBILITY OF THE CATHETER; 2) THE CHANGE OF THE INSERTION TIP AND ADHESIVE OF THE TARGIS MICROWAVE DELIVERY SYSTEM TO THE SAME CATHETER TYPE AS THE CTC MDS; AND 3) THE ADDITION OF TEXIN 950 UV STABILIZED TUBING FOR THE SHAFT OF THE CTC CATHETER. |