UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S052 · decided 2010-08-27
Approval details
- PMA number
- P970008
- Supplement
- S052
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2010-07-02
- Decision date
- 2010-08-27
- Days to decision
- 56 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- 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.
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