PMA P970008S004
- Device
- UROLOGIC TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S004
- Product code
- MEQ
- Decision date
- 1997-11-26
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- Approval for a change to the physician training manual for the addition of a module for patient comfort management.
Current openFDA PMA Record#
- Device
- UROLOGIC TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S004
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 1997-11-26
- Decision code
- APPR
- Date received
- 1997-11-21
- Supplement type
- Real-Time Process
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for a change to the physician training manual for the addition of a module for patient comfort management.