UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S023 · decided 2003-07-07
Approval details
- PMA number
- P970008
- Supplement
- S023
- 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
- 2003-01-09
- Decision date
- 2003-07-07
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR 1) THE RTU PLUS, A MODIFIED VERSION OF THE RECTAL THERMOSENSING UNIT (RTU), AND 2) LABELING CHANGES. THE RTU PLUS INCLUDES A DISPOSABLE BALLOON AND REUSABLE HANDLE, AND WILL BE AVAILABLE AS AN ALTERNATIVE TO THE EXISTING SINGLE USE RTU.
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