UROLOGIX TARGIS SYSTEM FOR THE TREATMENT OF BPH
FDA premarket approval P970008/S064 · decided 2015-08-28
Approval details
- PMA number
- P970008
- Supplement
- S064
- 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
- 2015-06-23
- Decision date
- 2015-08-28
- Days to decision
- 66 days
- Decision code
- APPR
- Product code
- MEQ
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Plymouth, MN
- Statement
- APPROVAL FOR MODIFICATIONS TO THE DESIGN AND MANUFACTURING PROCEDURES OF THE PATIENT CABLE.
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