PMA P970008S053
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S053
- Product code
- MEQ
- Decision date
- 2011-01-07
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE CTC ADVANCE MICROWAVE TREATMENT CATHETER TO INCORPORATE AN ADDITIONAL SET OF COOLANT OUTPUT HOLES.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S053
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2011-01-07
- Decision code
- APPR
- Date received
- 2010-11-16
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE CTC ADVANCE MICROWAVE TREATMENT CATHETER TO INCORPORATE AN ADDITIONAL SET OF COOLANT OUTPUT HOLES.