PMA P970008S030
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S030
- Product code
- MEQ
- Decision date
- 2006-03-20
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR UPGRADES TO THE TARGIS SYSTEM. THESE CHANGES INCLUDE IMPROVED APPEARANCE (WHICH REQUIRED REPLACING THE CONTROL UNIT EXTERIOR PANELS AND MOVING THE USER CONTROLS), IMPROVED ELECTROMAGNETIC COMPATIBILITY (EMC), AND OTHER COMPONENT AND MANUFACTURING MODIFICATIONS DUE TO COMPONENT OBSOLESCENCE.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S030
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2006-03-20
- Decision code
- APPR
- Date received
- 2005-11-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR UPGRADES TO THE TARGIS SYSTEM. THESE CHANGES INCLUDE IMPROVED APPEARANCE (WHICH REQUIRED REPLACING THE CONTROL UNIT EXTERIOR PANELS AND MOVING THE USER CONTROLS), IMPROVED ELECTROMAGNETIC COMPATIBILITY (EMC), AND OTHER COMPONENT AND MANUFACTURING MODIFICATIONS DUE TO COMPONENT OBSOLESCENCE.