UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S024 · decided 2005-02-18
Approval details
- PMA number
- P970008
- Supplement
- S024
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2004-09-30
- Decision date
- 2005-02-18
- Days to decision
- 141 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- 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.
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