TARGIS (T3) SYSTEM
FDA premarket approval P970008 · decided 1997-08-22
Approval details
- PMA number
- P970008
- Trade name
- TARGIS (T3) SYSTEM
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 1997-02-24
- Decision date
- 1997-08-22
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- Approval for the T3(R) Targeted Transurethral Thermoablation System: Model 4000. This device is indicated to relieve symptoms associated with benign prostatic hyperplasia (BPH) and is indicated for men with prostatic lengths of 30 to 50 millimeters.
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