PMA P970008S019
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S019
- Product code
- MEQ
- Decision date
- 2002-08-01
- Classification
- System, Hyperthermia, Rf/microwave (benign Prostatic Hyperplasia),thermotherapy
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE TARGIS SYSTEM LABELING REGARDING THE TREATMENT OF PATIENTS WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS).
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S019
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2002-08-01
- Decision code
- APPR
- Date received
- 2002-02-04
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE TARGIS SYSTEM LABELING REGARDING THE TREATMENT OF PATIENTS WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS).