THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM
FDA premarket approval P860003/S071 · decided 2013-08-08
Approval details
- PMA number
- P860003
- Supplement
- S071
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- THERAKOS CELLEX/UVAR XTS PHOTOPHERESIS SYSTEM
- Generic name
- System, photopheresis, extracorporeal
- Applicant
- Therakos Development Limited
- Date received
- 2013-02-22
- Decision date
- 2013-08-08
- Days to decision
- 167 days
- Decision code
- APPR
- Product code
- LNR
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Dublin
- Statement
- APPROVAL FOR CHANGES IN TWO MATERIALS USED IN MOLDING COMPONENTS OF THE UVAR® XTS® AND CELLEX® PROCEDURAL KITS.
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