UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S045 · decided 2006-12-22
Approval details
- PMA number
- P860003
- Supplement
- S045
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- UVAR XTS PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2006-11-22
- Decision date
- 2006-12-22
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR A MATERIAL CHANGE FOR THE SPIKE PORTION OF THE DRIP CHAMBER OF THE UVAR XTS PROCEDURAL KIT, WHICH IS USED WITH THE UVAR XTS PHOTOPHERESIS SYSTEM.
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