PMA P970008S025
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S025
- Product code
- MEQ
- Decision date
- 2005-02-15
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- 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.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S025
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2005-02-15
- Decision code
- APPR
- Date received
- 2005-02-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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.