- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S045
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2009-08-27
- Decision code
- APPR
- Date received
- 2009-07-14
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL TO REPLACE AN OBSOLETE CONNECTOR USED IN THE TARGIS AND CTC ADVANCE TREATMENT CATHETERS AND TO IMPROVE THE CONNECTOR JUNCTION IN THE CTC ADVANCE CATHETERS