UROLOGIC TARGIS SYSTEM
FDA premarket approval P970008/S006 · decided 1998-07-27
Approval details
- PMA number
- P970008
- Supplement
- S006
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- UROLOGIC TARGIS SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 1998-05-05
- Decision date
- 1998-07-27
- Days to decision
- 83 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for an expansion of the indication for use statement to include relief o obstruction. The indication for use, as modified, is "The Urologix Targis System is a non-surgical device intended to relieve symptoms and obstruction associated with Benign Prostatic Hyperplasia (BPH) and is indicated for men with prostatic urethra lengths of 30 to 50 mm.
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