PMA P970008S021
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S021
- Product code
- MEQ
- Decision date
- 2003-04-01
- 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 MICROWAVE DELIVERY SYSTEM (REFERRED TO AS THE "COOLED THERMOCATH") AND ASSOCIATED CHANGES TO THE TREATMENT PARAMETERS.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S021
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2003-04-01
- Decision code
- APPR
- Date received
- 2002-06-21
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- APPROVAL FOR MODIFICATIONS TO THE MICROWAVE DELIVERY SYSTEM (REFERRED TO AS THE "COOLED THERMOCATH") AND ASSOCIATED CHANGES TO THE TREATMENT PARAMETERS.