PMA P970008S064
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S064
- Product code
- MEQ
- Decision date
- 2015-08-28
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MANUFACTURING PROCEDURES OF THE PATIENT CABLE.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S064
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2015-08-28
- Decision code
- APPR
- Date received
- 2015-06-23
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MANUFACTURING PROCEDURES OF THE PATIENT CABLE.