PMA P970008S060
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S060
- Product code
- MEQ
- Decision date
- 2012-02-03
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE SOFTWARE FOR THE TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000 AND ASSOCIATED CHANGES TO THE USER MANUAL. THE DEVICE,AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE RELIEF OF SYMPTOMS AND OBSTRUCTIONS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 2.5-3.5CM (SHORT ANTENNA), OR 3.0-5.0CM (STANDARD ANTENNA), OR 4.5+CM (LONG ANTENNA).
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S060
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2012-02-03
- Decision code
- APPR
- Date received
- 2011-12-20
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MINOR CHANGES TO THE SOFTWARE FOR THE TARGIS SYSTEM COOLWAVE CONTROL UNIT MODEL 5000 AND ASSOCIATED CHANGES TO THE USER MANUAL. THE DEVICE,AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM AND IS INDICATED FOR THE RELIEF OF SYMPTOMS AND OBSTRUCTIONS ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) FOR MEN WITH PROSTATIC URETHRAL LENGTHS OF 2.5-3.5CM (SHORT ANTENNA), OR 3.0-5.0CM (STANDARD ANTENNA), OR 4.5+CM (LONG ANTENNA).