PMA P970008S031
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S031
- Product code
- MEQ
- Decision date
- 2007-03-19
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- CHANGE THE RECTAL THERMOSENSING UNIT (RTU) PLUS TEMPERATURE SENSOR CHANNEL WIDTH AND WELD THE T-WELD CORNERS WITH A GRADUAL RADIUS TURN.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S031
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2007-03-19
- Decision code
- OK30
- Date received
- 2007-02-20
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- CHANGE THE RECTAL THERMOSENSING UNIT (RTU) PLUS TEMPERATURE SENSOR CHANNEL WIDTH AND WELD THE T-WELD CORNERS WITH A GRADUAL RADIUS TURN.