UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S038 · decided 2008-09-02
Approval details
- PMA number
- P970008
- Supplement
- S038
- 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
- 2008-03-10
- Decision date
- 2008-09-02
- Days to decision
- 176 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR THE ADDITION OF THE CTC ADVANCE MICROWAVE CATHETER 2.5-3.5 CM (MODEL NUMBER TV1321C).
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