UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
FDA premarket approval P970008/S045 · decided 2009-08-27
Approval details
- PMA number
- P970008
- Supplement
- S045
- 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
- 2009-07-14
- Decision date
- 2009-08-27
- Days to decision
- 44 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL TO REPLACE AN OBSOLETE CONNECTOR USED IN THE TARGIS AND CTC ADVANCE TREATMENT CATHETERS AND TO IMPROVE THE CONNECTOR JUNCTION IN THE CTC ADVANCE CATHETERS
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