PMA P970008S034
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S034
- Product code
- MEQ
- Decision date
- 2008-04-07
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR 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.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S034
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2008-04-07
- Decision code
- APPR
- Date received
- 2007-10-17
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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.