UROLOGIX TARGIS SYSTEM
FDA premarket approval P970008/S001 · decided 1997-08-28
Approval details
- PMA number
- P970008
- Supplement
- S001
- 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
- 1997-08-26
- Decision date
- 1997-08-28
- Days to decision
- 2 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for a change in trade name. The device will be marketed under the trade anme Urologix Targis(TM) system and is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) in ment with prostatic lengths of 30 to 50 millimeters.
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