UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S034 · decided 2008-04-07
Approval details
- PMA number
- P970008
- Supplement
- S034
- Supplement type
- Normal 180 Day Track
- 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
- 2007-10-17
- Decision date
- 2008-04-07
- Days to decision
- 173 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR SOFTWARE CHANGES TO THE TARGIS CONTROL UNIT MODEL 4000 AND COOLWAVE CONTROL UNIT MODEL 5000 AND A RELATED LABELING CHANGE TO THE USER MANUAL FOR THE COOLWAVE CONTROL UNIT.
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