PMA P970008S023
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S023
- Product code
- MEQ
- Decision date
- 2003-07-07
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order 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.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S023
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2003-07-07
- Decision code
- APPR
- Date received
- 2003-01-09
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.