PMA P970008S048
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S048
- Product code
- MEQ
- Decision date
- 2010-04-30
- 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 UROLOGIX TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000A.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S048
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2010-04-30
- Decision code
- APPR
- Date received
- 2010-03-03
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR SOFTWARE CHANGES TO THE UROLOGIX TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000A.