PMA P970008S013
- Device
- UROLOGIX TARGIS(TM) SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S013
- Product code
- MEQ
- Decision date
- 2000-06-05
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR THE 28.5 MINUTE TREATMENT OPTION.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS(TM) SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S013
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2000-06-05
- Decision code
- APPR
- Date received
- 1999-12-16
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR THE 28.5 MINUTE TREATMENT OPTION.