UVAR XTS PROCEDURAL KIT
FDA premarket approval P860003/S055 · decided 2011-01-25
Approval details
- PMA number
- P860003
- Supplement
- S055
- Supplement type
- 135 Review Track For 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- UVAR XTS PROCEDURAL KIT
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2010-09-01
- Decision date
- 2011-01-25
- Days to decision
- 146 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR USE OF A NEW WELDER IN MANUFACTURING THE CENTRIFUGE BOWL.
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