PMA P970008S024
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S024
- Product code
- MEQ
- Decision date
- 2005-02-18
- 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 PROSTATRON LABELING REGARDING THE TREATMENT OF PATIENTS 1) WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS), 2) IN URINARY RETENTION, AND 3) WITH MEDIAN PROSTATIC LOBES.
Current openFDA PMA Record#
- Device
- UROLOGIX TARGIS SYSTEM
- Applicant
- Urologix, LLC
- PMA number
- P970008
- Supplement
- S024
- Product code
- MEQ
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Decision date
- 2005-02-18
- Decision code
- APPR
- Date received
- 2004-09-30
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- APPROVAL FOR MODIFICATION OF THE PROSTATRON LABELING REGARDING THE TREATMENT OF PATIENTS 1) WITH IMPLANTED ACTIVE DEVICES (INCLUDING PACEMAKERS AND DEFIBRILLATORS), 2) IN URINARY RETENTION, AND 3) WITH MEDIAN PROSTATIC LOBES.