UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
FDA premarket approval P970008/S036 · decided 2008-03-31
Approval details
- PMA number
- P970008
- Supplement
- S036
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
- Generic name
- System, hyperthermia, rf/microwave (benign prostatic hyperplasia),thermotherapy
- Applicant
- Urologix, LLC
- Date received
- 2008-01-31
- Decision date
- 2008-03-31
- Days to decision
- 60 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR CHANGES TO THE MATERIALS, COLOR, ANTENNA DESIGN, COOLANT PATH FUNCTIONS AND DESIGN OF THE COOLED THERMOCATH CATHETER. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CTC ADVANCE AND IS INDICATED TO RELIEVE SYMPTOMS AND OBSTRUCTION ASSOCIATED WITH BENIGN PROSTATIC HYPERPLASIA (BPH) AND IS INDICATED FOR MEN WITH PROSTATIC URETHRA LENGTHS OF 3.5 ? 5.0 CM (MODEL NUMBER TC1121C) OR 4.5+ CM (MODEL NUMBER TF1221C).
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