PMA P970008S052
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S052
- Product code
- MEQ
- Decision date
- 2010-08-27
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR: 1) MODIFICATION OF THE RFID PROGRAMMING; 2) MODIFICATION OF THE COIL GAP MEASUREMENT; 3) ADDITION OF A COOLING SYSTEM GASKET; 4) SUBSTITUTION OF A LOCK SCREW; AND 5) SOFTWARE UPDATED TO DIFFERENTIATE CATHETER MODELS, CLOSE ERROR MESSAGES ON RESTART, AND ADD A PRECONFIGURED CONTROL UNIT PROTOCOL SETTING.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S052
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2010-08-27
- Decision code
- APPR
- Date received
- 2010-07-02
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR: 1) MODIFICATION OF THE RFID PROGRAMMING; 2) MODIFICATION OF THE COIL GAP MEASUREMENT; 3) ADDITION OF A COOLING SYSTEM GASKET; 4) SUBSTITUTION OF A LOCK SCREW; AND 5) SOFTWARE UPDATED TO DIFFERENTIATE CATHETER MODELS, CLOSE ERROR MESSAGES ON RESTART, AND ADD A PRECONFIGURED CONTROL UNIT PROTOCOL SETTING.