PMA P970008S035
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S035
- Product code
- MEQ
- Decision date
- 2008-03-07
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR COMPONENT CHANGES TO THE MICROWAVE GENERATOR SUBASSEMBLY USED IN THE TARGIS SYSTEM CONTROL UNIT MODEL 4000 AND IN THE COOLWAVE CONTROL UNIT MODEL 5000.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S035
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2008-03-07
- Decision code
- APPR
- Date received
- 2008-01-09
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR COMPONENT CHANGES TO THE MICROWAVE GENERATOR SUBASSEMBLY USED IN THE TARGIS SYSTEM CONTROL UNIT MODEL 4000 AND IN THE COOLWAVE CONTROL UNIT MODEL 5000.