PMA P970008S058
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S058
- Product code
- MEQ
- Decision date
- 2011-12-09
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR DEVICE AND MANUFACTURING MODIFICATIONS OF THE TIP OF THE CTC ADVANCED CATHETER COMPONENT OF THE TARGIS SYSTEM.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S058
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2011-12-09
- Decision code
- APPR
- Date received
- 2011-07-01
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR DEVICE AND MANUFACTURING MODIFICATIONS OF THE TIP OF THE CTC ADVANCED CATHETER COMPONENT OF THE TARGIS SYSTEM.