UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S018 · decided 2002-09-04
Approval details
- PMA number
- P970008
- Supplement
- S018
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2001-12-03
- Decision date
- 2002-09-04
- Days to decision
- 275 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR A CHANGE FROM THE STANDARD ANTENNA (2.8 CM IN LENGTH) TO A SHORTENED VERSION (2.0 CM IN LENGTH). THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME UROLOGIX TARGIS SYSTEM, AND IS INTENDED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASMIA (BPH), AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 2.5 TO 3.5 CM.
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