PMA P970008S028
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S028
- Product code
- MEQ
- Decision date
- 2006-02-06
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE CONTROL UNIT (TARGIS "COOL WAVE" CONTROL UNIT MODEL 5000A OR NEXT GENERATION CONTROL UNIT - NGCU), SOFTWARE, AND OPERATING MODES FOR BOTH THE TARGIS MICROWAVE DELIVERY SYSTEM (MDS) AND TARGIS COOLED THERMOCATH MDS.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S028
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2006-02-06
- Decision code
- APPR
- Date received
- 2005-04-28
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE CONTROL UNIT (TARGIS "COOL WAVE" CONTROL UNIT MODEL 5000A OR NEXT GENERATION CONTROL UNIT - NGCU), SOFTWARE, AND OPERATING MODES FOR BOTH THE TARGIS MICROWAVE DELIVERY SYSTEM (MDS) AND TARGIS COOLED THERMOCATH MDS.