PMA P970008S026
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S026
- Product code
- MEQ
- Decision date
- 2005-06-16
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR A LONGER VERSION OF THE COOLED THERMOCATH MICROWAVE DELIVERY CATHETER. THE LONGER ANTENNA IS 37 MM COMPARED TO THE 28 MM ANTENNA IN THE CURRENTLY APPROVED COOLED THERMOCATH CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLED THERMOCATH 4.5+ AND IS INDICATED FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 4.5 CM OR GREATER.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S026
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2005-06-16
- Decision code
- APPR
- Date received
- 2005-02-25
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR A LONGER VERSION OF THE COOLED THERMOCATH MICROWAVE DELIVERY CATHETER. THE LONGER ANTENNA IS 37 MM COMPARED TO THE 28 MM ANTENNA IN THE CURRENTLY APPROVED COOLED THERMOCATH CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME COOLED THERMOCATH 4.5+ AND IS INDICATED FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 4.5 CM OR GREATER.