PMA P970008S036
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S036
- Product code
- MEQ
- Decision date
- 2008-03-31
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- 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).
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S036
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2008-03-31
- Decision code
- APPR
- Date received
- 2008-01-31
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- 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).