UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S049 · decided 2010-05-13
Approval details
- PMA number
- P970008
- Supplement
- S049
- 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
- 2010-03-17
- Decision date
- 2010-05-13
- Days to decision
- 57 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL TO REPLACE AN OBSOLETE TOUCHSCREEN AND MODIFY THE MICROWAVE GENERATOR TO IMPROVE DESIGN MARGINS.
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